Dual Frequency Stimulation in Parkinson's Disease

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04650932
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Deep brain stimulation — DEVICE
    Patients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.

Study Details

Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.

Key Dates

Start date
Oct 22, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sustained Dual Frequency, Dual Region, Stimulation

Primary Outcome Measure

Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Week 2, Week 6, Month 3, and Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95817
Jessica Beatty, MS
[email protected]
916-734-0901
Janice Wang-Polagruto, PhD, CCRP
[email protected]
916-551-3244

Find similar trials in Sacramento, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UC Davis Health· Sacramento, CA

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