Trial Outcomes & Findings for Deep Brain Stimulation in Patients With Dystonia (NCT NCT00773604)
NCT ID: NCT00773604
Last Updated: 2019-02-19
Results Overview
Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)
COMPLETED
NA
9 participants
Baseline and 12 months
2019-02-19
Participant Flow
Participant milestones
| Measure |
Open Label Cohort
This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep Brain Stimulation in Patients With Dystonia
Baseline characteristics by cohort
| Measure |
Open Label Cohort
n=9 Participants
This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
|
|---|---|
|
Age, Continuous
|
48.95 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Patients implanted and treated with DBS
Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)
Outcome measures
| Measure |
Open Label Cohort
n=9 Participants
This was a single arm open label study of 9 patients who were treated with STN DBS for isolated dystonia
|
|---|---|
|
The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months
|
33.5 TWSTRS total score change
Interval 9.2 to 57.75
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=9 participants at risk
DBS treatment patients
|
|---|---|
|
Nervous system disorders
Dyskinesia
|
88.9%
8/9
|
|
Psychiatric disorders
Depression, transient worsening
|
55.6%
5/9
|
|
Metabolism and nutrition disorders
Weight gain
|
44.4%
4/9
|
|
Psychiatric disorders
Anxiety, worsened
|
22.2%
2/9
|
|
Nervous system disorders
Dysarthria
|
22.2%
2/9
|
|
Nervous system disorders
Dysphasia
|
22.2%
2/9
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Transient erythema around parietal incision site
|
11.1%
1/9
|
|
Surgical and medical procedures
Subgaleal cerebral fluid collection around burr-hole cap
|
11.1%
1/9
|
|
Surgical and medical procedures
Persistent pain at IPG site
|
11.1%
1/9
|
|
Nervous system disorders
Shock-like sensations
|
11.1%
1/9
|
|
Nervous system disorders
Migraine headaches, worsened
|
11.1%
1/9
|
|
Nervous system disorders
Sensory deficit in hand, worsened
|
11.1%
1/9
|
|
Nervous system disorders
Lower extremity paresthesias
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Blood pressure instability
|
11.1%
1/9
|
|
Nervous system disorders
Fall
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Knee dislocation
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Knee injury
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Hip pain, worsened
|
11.1%
1/9
|
|
Nervous system disorders
Fourth cranial nerve palsy, preexisting
|
11.1%
1/9
|
|
General disorders
Handwriting difficulties
|
11.1%
1/9
|
|
Ear and labyrinth disorders
Humming sounds in ear, worsened
|
11.1%
1/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place