Trial Outcomes & Findings for A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial (NCT NCT03350750)
NCT ID: NCT03350750
Last Updated: 2022-08-02
Results Overview
Evaluation of CSF shunting in Idiopathic Normal Pressure Hydrocephalus (INPH) patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity in meters per second (m/s).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline and 4 months
Results posted on
2022-08-02
Participant Flow
Participant milestones
| Measure |
Open Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable cerebrospinal fluid (CSF) shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
4-month Follow-up (Randomized Evaluation)
|
8
|
8
|
|
Overall Study
12-Month Follow-up (Entire Study)
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Open Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable cerebrospinal fluid (CSF) shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
Baseline characteristics by cohort
| Measure |
Open Shunt Group
n=9 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=9 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.0 years
n=39 Participants
|
74.5 years
n=41 Participants
|
74.2 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Evans' Ratio
|
0.36 no unit
n=39 Participants
|
0.37 no unit
n=41 Participants
|
0.37 no unit
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsPopulation: Randomized patients alive at Month 4
Evaluation of CSF shunting in Idiopathic Normal Pressure Hydrocephalus (INPH) patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity in meters per second (m/s).
Outcome measures
| Measure |
Open Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Gait Velocity
|
0.28 meters per second
Standard Deviation 0.284
|
0.04 meters per second
Standard Deviation 0.167
|
SECONDARY outcome
Timeframe: Baseline and 4 MonthsPopulation: Randomized patients alive at Month 4
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MoCA test to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
Outcome measures
| Measure |
Open Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) Score
|
-0.13 score on a scale
Standard Deviation 3.643
|
1.63 score on a scale
Standard Deviation 1.598
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsPopulation: Randomized patients alive at Month 4 with Outcome Data at Baseline and Month 4.
Evaluate the effect of shunting between active and placebo-controlled groups at four months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
Outcome measures
| Measure |
Open Shunt Group
n=6 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Bladder Control as Assessed by the Overactive Bladder Questionnaire, Short Form
|
-23.3 score on a scale
Standard Deviation 19.89
|
2.1 score on a scale
Standard Deviation 17.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsPopulation: Randomized Patients alive at Month 4 with Outcome Data for both Baseline and Month 4.
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
Outcome measures
| Measure |
Open Shunt Group
n=7 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Function as Assessed by the Lawton Activities of Daily Living/Independence in Activities of Daily Living (ADL/IADL) Test Score
|
-5.7 score on a scale
Standard Deviation 6.73
|
1.4 score on a scale
Standard Deviation 3.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsPopulation: Randomized Patients Alive at Month 4.
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Outcome measures
| Measure |
Open Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Function as Assessed by the Modified Rankin Scale (MRS)
|
-0.88 score on a scale
Standard Deviation 1.126
|
-0.13 score on a scale
Standard Deviation 0.641
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsPopulation: Randomized Patients Alive at Month 4.
Evaluate the effect of shunting between active and placebo-controlled groups at four months using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
Outcome measures
| Measure |
Open Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=8 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Cognition as Assessed by the Symbol Digit Modalities Test (SDMT)
|
-0.3 score on a scale
Standard Deviation 6.61
|
-0.1 score on a scale
Standard Deviation 4.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 months after active shuntingPopulation: All randomized patients alive with gait velocity evaluated 8 months after active shunting.
Evaluate the clinical improvement of all study participants at eight months of active shunting, using the primary outcome of gait velocity. For patients assigned to Open shunt, active shunting is from Baseline to Month 8 of the study. For patients assigned to Closed Shunt, active shunting is from Month 4 of the study (immediately prior to opening of initially Closed shunt) to Month 12 (i.e., after 8 months of the patient having an open shunt).
Outcome measures
| Measure |
Open Shunt Group
n=13 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Gait Velocity From Shunt Activation to 8 Months After Active Shunting
|
0.38 meters per second
Standard Deviation 0.229
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 months after active shuntingPopulation: all patients with MoCA available at baseline and after 8 months of active shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using MoCA to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
Outcome measures
| Measure |
Open Shunt Group
n=13 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Cognition Using MoCA From Baseline to 8 Months After Active Shunting
|
1.0 score on a scale
Standard Deviation 2.92
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 months after active shuntingPopulation: Patients with outcome data available at baseline and at 8 months after active shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using OAB-q test to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
Outcome measures
| Measure |
Open Shunt Group
n=12 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Bladder Control From Baseline to 8 Months After Active Shunting
|
-25.0 score on a scale
Standard Deviation 29.42
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 months after active shuntingPopulation: All participants with outcome data available at baseline and after 8 months of active shunting
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
Outcome measures
| Measure |
Open Shunt Group
n=12 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Function Using ADL/IADL From Baseline to 8 Months After Active Shunting
|
-4.7 score on a scale
Standard Deviation 5.88
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 months after active shuntingPopulation: All randomizred patients with MRS data at baseline and at 8 months of active shunting.
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Outcome measures
| Measure |
Open Shunt Group
n=13 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Function Using MRS From Baseline to 8 Months After Active Shunting
|
-0.6 score on a scale
Standard Deviation 0.96
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 8 months after active shuntingPopulation: All patients with SDMT data available at baseline and 8 months after active shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
Outcome measures
| Measure |
Open Shunt Group
n=13 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Change in Cognition Using SDMT From Baseline to 8 Months After Active Shunting
|
5.8 score on a scale
Standard Deviation 7.21
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 monthsEvaluate the effect of shunting between active and placebo-controlled groups at four months by assessing the number of patients with falls.
Outcome measures
| Measure |
Open Shunt Group
n=9 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=9 Participants
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Number of Patients With Falls
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 monthsEvaluate the clinical improvement of all study participants at eight months of active shunting by assessing the frequency of falls, surgical and non-surgical complications, related and unrelated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 and 8 months of active shuntingCompare adverse events (AEs) in the active versus placebo-controlled group at four months and at eight months of active shunting.
Outcome measures
Outcome data not reported
Adverse Events
Open Shunt Group
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Closed Shunt Group
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Open Shunt Group
n=9 participants at risk
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=9 participants at risk
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Infections and infestations
Urosepsis
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Nervous system disorders
Subdural Effusion
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
Other adverse events
| Measure |
Open Shunt Group
n=9 participants at risk
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
Closed Shunt Group
n=9 participants at risk
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
programmable CSF shunt valve: Brain shunt surgery using a programmable CSF shunt valve
|
|---|---|---|
|
Investigations
Transient Decrease in MOCA Score
|
44.4%
4/9 • Number of events 6 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Nervous system disorders
Balance disorder
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
11.1%
1/9 • Number of events 1 • From time of randomization until 1 year after initial shunting procedure.
There are two intervention groups in the study. Open shunt arm starts with shunt "active" at the time of shunt insertion. Closed shunt arm begins with an initial 4-month period where shunt is set to placebo and then to active after 4 months of shunt insertion. Adverse events were assessed for these two arms. Adverse events occurring during the period of the closed shunt were not separately monitored from adverse events occurring during the period of the open shunt for the Closed shunt group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place