Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT05307055
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STN DBS - Theta Burst — DEVICE
    200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device
  • STN DBS - Gamma — DEVICE
    Standard of care gamma stimulation with an existing device

Study Details

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.

Key Dates

Start date
Jan 11, 2022
Status verified
Jun 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Evaluation of motor symptoms [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern California Keck School of MedicineLos AngelesCalifornia90033
Darrin Lee
[email protected]
949-522-0866
Wooseong Choi
[email protected]
8474017335

Find similar trials in Los Angeles, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Southern California Keck School of Medicine· Los Angeles, CA

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