Trial Outcomes & Findings for Parkinson Disease and DBS: Cognitive Effects in GBA Mutation Carriers (NCT NCT03234478)
NCT ID: NCT03234478
Last Updated: 2026-07-29
Results Overview
Mattis Dementia Rating Scale Unit of Measure: Scores on a scale. Scale range: Total score ranges from 0 to 144. Interpretation: Higher scores indicate better cognitive functioning, while lower scores indicate greater cognitive impairment. Calculation of total score: The total score is calculated by summing the scores from the individual cognitive domains measured in each subscale. Subscale scores not available for this study.
COMPLETED
150 participants
2 years
2026-07-29
Participant Flow
We used pooled retrospective data as part of our analysis. Thus 366 patients data was examined, but only 150 enrolled. For our analysis, we combined the retrospective data with the data from 150 subjects enrolled.
Participant milestones
| Measure |
GBA Mutation Carriers Without DBS
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers Without DBS
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
GBA Mutation Carriers With DBS
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers With DBS
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
128
|
58
|
98
|
|
Overall Study
COMPLETED
|
82
|
128
|
58
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing data
Baseline characteristics by cohort
| Measure |
GBA Mutation Carriers Without DBS
n=82 Participants
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers Without DBS
n=128 Participants
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
GBA Mutation Carriers With DBS
n=58 Participants
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers With DBS
n=98 Participants
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.42 years
STANDARD_DEVIATION 9.55 • n=80 Participants • missing data
|
61.44 years
STANDARD_DEVIATION 9.50 • n=128 Participants • missing data
|
57.19 years
STANDARD_DEVIATION 7.48 • n=58 Participants • missing data
|
58.28 years
STANDARD_DEVIATION 8.31 • n=98 Participants • missing data
|
59.33 years
STANDARD_DEVIATION 8.71 • n=364 Participants • missing data
|
|
Sex: Female, Male
Female
|
37 Participants
n=80 Participants • missing data
|
48 Participants
n=128 Participants • missing data
|
20 Participants
n=58 Participants • missing data
|
32 Participants
n=98 Participants • missing data
|
137 Participants
n=364 Participants • missing data
|
|
Sex: Female, Male
Male
|
43 Participants
n=80 Participants • missing data
|
80 Participants
n=128 Participants • missing data
|
38 Participants
n=58 Participants • missing data
|
66 Participants
n=98 Participants • missing data
|
227 Participants
n=364 Participants • missing data
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 2 yearsMattis Dementia Rating Scale Unit of Measure: Scores on a scale. Scale range: Total score ranges from 0 to 144. Interpretation: Higher scores indicate better cognitive functioning, while lower scores indicate greater cognitive impairment. Calculation of total score: The total score is calculated by summing the scores from the individual cognitive domains measured in each subscale. Subscale scores not available for this study.
Outcome measures
| Measure |
GBA Mutation Carriers Without DBS
n=82 Participants
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers Without DBS
n=128 Participants
Parkinson's disease patients who have moderate to advanced disease but have not undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
GBA Mutation Carriers With DBS
n=58 Participants
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
Non-mutation Carriers With DBS
n=98 Participants
Parkinson's disease patients who have moderate to advanced disease and have undergone deep brain stimulation. Subjects will be tested for GBA mutation status as part of this study.
|
|---|---|---|---|---|
|
Mattis Dementia Rating Scale
|
-0.7 points
Interval -1.1 to -0.3
|
-0.4 points
Interval -0.7 to -0.1
|
-2.4 points
Interval -2.7 to -2.1
|
-0.9 points
Interval -1.2 to -0.6
|
Adverse Events
GBA Mutation Carriers Without DBS
Non-mutation Carriers Without DBS
GBA Mutation Carriers With DBS
Non-mutation Carriers With DBS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place