Bradykinesia, Parkinson's Disease, Tremor
Conditions
Keywords
Parkinson's disease, Tremor, Bradykinesia, Deep brain stimulation, Kinesia
Brief summary
The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.
Interventions
DEVICEAutomated Programming
Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Great Lakes NeuroTechnologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of idiopathic Parkinson's disease * Implanted deep brain stimulation system awaiting initial programming session
Exclusion criteria
* Subjects with significant psychiatric illness or dementia * Significant cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming | Within two days of standard clinical DBS programming session | Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Automated Programming Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.
Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Automated Programming |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 62 years |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming
Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.
Time frame: Within two days of standard clinical DBS programming session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Programming | Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming | -35.7 Percentage change | Standard Deviation 37.8 |