Trial Outcomes & Findings for Thalamic Deep Brain Stimulation for Spasmodic Dysphonia- DEBUSSY Trial (NCT NCT02558634)
NCT ID: NCT02558634
Last Updated: 2022-06-14
Results Overview
Assessments of spasmodic dysphonia using a standardized spasmodic dysphonia rating scale were done pre-operatively, blinded DBS ON, blinded DBS OFF, and open DBS ON. Voice recording taken of each patient reading standardized sentences were blinded and evaluated by two speech language pathologists. The scale ranges from 0-7, with lower scores being better and higher scores being worse.
COMPLETED
NA
6 participants
After the first 6 months, the participants completed the USDRS twice (once per crossover).
2022-06-14
Participant Flow
Participant milestones
| Measure |
DBS-on First, Then DBS-off (Sham-stimulation)
Ventral intermediate Nucleus (VIM) Thalamic DBS on for the first 3 months, then Thalamic DBS off for the next 3 months
DBS system includes:
* Implantable Pulse Generator (IPG)
* DBS Lead
* DBS Lead Extension Kit
VIM Thalamic DBS ON for first 3 months, then Thalamic DBS OFF for following 3 months
|
DBS-off First (Sham-stimulation), Then DBS-on
Ventral intermediate Nucleus (VIM) Thalamic DBS off (Sham-stimulation) for the first 3 months, then Thalamic DBS on for the following 3 months
DBS system includes:
* Implantable Pulse Generator (IPG)
* DBS Lead
* DBS Lead Extension Kit
VIM Thalamic Deep Brain Stimulation OFF for first 3 months, followed by VIM Thalamic Deep Brain Stimulation ON for the following 3 months
|
|---|---|---|
|
Blinded: First Intervention (3 Months)
STARTED
|
4
|
2
|
|
Blinded: First Intervention (3 Months)
COMPLETED
|
4
|
2
|
|
Blinded: First Intervention (3 Months)
NOT COMPLETED
|
0
|
0
|
|
Blinded: Second Intervention (3 Months)
STARTED
|
4
|
2
|
|
Blinded: Second Intervention (3 Months)
COMPLETED
|
3
|
2
|
|
Blinded: Second Intervention (3 Months)
NOT COMPLETED
|
1
|
0
|
|
Unblinded: DBS on (6 Months)
STARTED
|
4
|
2
|
|
Unblinded: DBS on (6 Months)
COMPLETED
|
4
|
2
|
|
Unblinded: DBS on (6 Months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=6 Participants
1. Patients who are currently receiving BTX injections for their voice disorder
2. Who experience fluctuations in their symptom control as a result of their BTX therapy
3. Patients who fall into the age range of 18-75 years old
|
|---|---|
|
Age, Continuous
|
65.17 years
STANDARD_DEVIATION 8.27 • n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
Canada
|
6 Participants
n=6 Participants
|
|
Patients who are currently receiving BTX injections for their voice disorder
|
6 Participants
n=6 Participants
|
|
Patients who experience fluctuations in their symptom control as a result of their BTX therapy
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: After the first 6 months, the participants completed the USDRS twice (once per crossover).Population: One patient requested to have their DBS on after 2 weeks of being in the blinded-DBS OFF after the first crossover.
Assessments of spasmodic dysphonia using a standardized spasmodic dysphonia rating scale were done pre-operatively, blinded DBS ON, blinded DBS OFF, and open DBS ON. Voice recording taken of each patient reading standardized sentences were blinded and evaluated by two speech language pathologists. The scale ranges from 0-7, with lower scores being better and higher scores being worse.
Outcome measures
| Measure |
Blinded-DBS ON
n=6 Participants
All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
|
Blinded-DBS OFF
n=5 Participants
All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
|
|---|---|---|
|
Unified Spasmodic Dysphonia Rating Scale (USDRS)
|
2.5 units on a scale
Standard Deviation 1.4
|
3.75 units on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: After the first 6 months, the participants completed the V-RQoL twice (once per crossover).Double-blinded assessments of voice-related quality of life with DBS ON/OFF were conducted using the V-RQoL for Spasmodic Dysphonia. The V-RQoL is a questionnaire that measures a patient's voice related quality of life. The scale ranges from 0-50, with higher scores representing a lower quality of life with respect to voice.
Outcome measures
| Measure |
Blinded-DBS ON
n=6 Participants
All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
|
Blinded-DBS OFF
n=5 Participants
All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
|
|---|---|---|
|
Voice-Related Quality of Life
|
74.7 units on a scale
Standard Deviation 18.3
|
19 units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: All participants completed the BDI-II once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).Beck's Depression Inventory Scale (BDI-II) was used in this study to evaluate the mood of the patients both pre-operatively and at the end of the one-year study. All 6 patients completed the BDI-II, which is a scale that identifies symptoms and attitudes associated with depression, and evaluates the presence and severity of depression. The BDI-II ranges from 0-63. Scores ranging from 0-10 are considered to be absent or minimal depression, 10-18 indicate mild to moderate depression, 19-29 indicate moderate depression, and 30-63 indicate severe depression.
Outcome measures
| Measure |
Blinded-DBS ON
n=6 Participants
All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
|
Blinded-DBS OFF
All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
|
|---|---|---|
|
Beck's Depression Inventory Scale
Pre-Operative BDI-II
|
13.33 units on a scale
Standard Deviation 7.20
|
—
|
|
Beck's Depression Inventory Scale
One Year Follow-Up BDI-II
|
6.50 units on a scale
Standard Deviation 6.47
|
—
|
SECONDARY outcome
Timeframe: All participants completed the MoCA once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).The MoCA was used to analyze the cognitive ability of the patients. It was first evaluated pre-operatively and again evaluated at the end of the one-year study. The MoCA scale ranges from 0-30 with higher scores indicating less cognitive impairment. Scores ranging from 18-25 indicate mild cognitive impairment, 10-17 indicate moderate cognitive impairment, and scores less than 10 indicate severe cognitive impairment.
Outcome measures
| Measure |
Blinded-DBS ON
n=6 Participants
All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
|
Blinded-DBS OFF
All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
|
|---|---|---|
|
Montreal Cognitive Assessment Scale (MoCA)
Pre-Operative MoCA
|
24.17 units on a scale
Standard Deviation 3.08
|
—
|
|
Montreal Cognitive Assessment Scale (MoCA)
One Year Follow-Up MoCA
|
26.67 units on a scale
Standard Deviation 3.09
|
—
|
SECONDARY outcome
Timeframe: All participants completed the VHI once pre-operatively and once 1 year post-operatively (after the 6-month open unblinded phase).The Voice-Handicap Index (VHI) is a questionnaire that measures the patients' perceived degree of handicap related to their voice. The VHI ranges from a scale of 0-100, with higher scores reflecting higher perceived degree of voice handicap and lower scores reflecting lower perceived degree of voice handicap.
Outcome measures
| Measure |
Blinded-DBS ON
n=6 Participants
All participants who at some point in the study were in the 3-month blinded DBS ON intervention.
|
Blinded-DBS OFF
All participants who at some point in the study were in the 3-month blinded DBS OFF intervention.
|
|---|---|---|
|
Voice-Handicap Index
Pre-Operative VHI
|
84.83 units on a scale
Standard Deviation 15.52
|
—
|
|
Voice-Handicap Index
1 Year Post-Operative VHI
|
38.17 units on a scale
Standard Deviation 13.15
|
—
|
Adverse Events
Blinded DBS-ON
Blinded DBS-OFF
Open DBS-ON
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amanda Chisholm, Manager, Internal Awards
Vancouver Coastal Health Research Association
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place