Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to determine whether direct brain stimulation of specific regions and ranges improves cognition in people with Parkinsons Disease (PD) who already have a deep brain stimulator implanted. Research activities consist of 32 subjects undergoing stimulation changes to their device and being administered neurocognitive tests to evaluate the changes. An fMRI scan will also be done at baseline and at weeks 15 and 27. All subjects will undergo the stimulation changes in a randomized double blind crossover study. Evaluation of stimulation changes will be assessed through analysis of neurocognitive data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation

• Age \>18 years old

• Stable medication regimen for at least 3 months.

• Patient informed and able to give written consent

• Able to comply with all testing, follow-ups and study appointments and protocols

Locations
United States
California
University of Southern California Keck School of Medicine
RECRUITING
Los Angeles
Contact Information
Primary
Darrin Lee, MD PhD
darrin.lee@med.usc.edu
9495220866
Backup
Wooseong Choi, BS
wooseong@usc.edu
8474017335
Time Frame
Start Date: 2022-01-11
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 40
Treatments
Experimental: Group A
double-blinded randomization into theta burst stimulation followed by baseline stimulation
Experimental: Group B
double blinded randomization into baseline stimulation followed by theta burst stimulation
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov