Pilot Study for Automated Deep Brain Stimulation Programming
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|ClinicalTrials.gov Identifier: NCT02046863|
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : August 9, 2016
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Tremor Bradykinesia||Device: Automated Programming||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: 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.
Device: Automated Programming
Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
- Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming [ Time Frame: 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.
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): NCT02046863
|United States, Ohio|
|University of Cincinnati Department of Neurology|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Dustin A Heldman, PhD||Great Lakes NeuroTechnologies|