Neural Signatures of Parkinson's Disease (BrainRadio)
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|ClinicalTrials.gov Identifier: NCT01990313|
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : January 16, 2018
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Activa PC+S||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neural Signatures of Tremor, Bradykinesia and Freezing in the Subthalamic Region on Parkinson's Disease and Their Acute and Long-Term Modulation by Subthalamic Deep Brain Stimulation.|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
|Experimental: Activa PC+S||
Device: Activa PC+S
The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
Other Name: Model 37604
- Change in Resting State Beta Band Power Over Time [ Time Frame: Baseline and 1 Year ]We compared the beta band (13-30 Hz) power in the neural signal at the initial programming visit (baseline) and at the 12 month follow-up visit (1 year) after turning off deep brain stimulation therapy. Beta band power is normalized to average beta band power at the initial programming visit. Using a linear mixed model for repeated measures over time, regression beta coefficient was obtained to determine if beta power changed significantly between the initial programming and the 12 month follow-up visit.
- Sample Beta Entropy [ Time Frame: 1 day ]Sample entropy is a measure of estimated conditional predictability, calculated within a frequency range of a patient's local field potential. Freezers are subjects who have clinical history of freezing of gait symptoms and/or if the subject displayed freezing behavior pre-operatively or during the in-study gait tasks relative to non-freezers, those who have never experienced freezing of gait. We measured sample beta (13-30 Hz) entropy in subjects' local field potential. Higher values of sample entropy indicate lower estimated conditional predictability. Testing occurred over one day, at a range of approximately 1 month to 7 months post DBS device implantation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990313
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Helen Bronte-Stewart, MD,MSE,FAAN||Stanford University|