Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Who is this study for? Patients with Parkinson's disease
What treatments are being studied? Deep brain stimulation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

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

• Individuals who are 18 years and older

• Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system

• Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months

• Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN

Locations
United States
California
UC Davis Health
RECRUITING
Sacramento
Contact Information
Primary
Kiarash Shahlaie, MD, PhD
krshahlaie@ucdavis.edu
916-703-5505
Backup
Janice Wang-Polagruto, PhD, CCRP
jfwang@ucdavis.edu
916-551-3244
Time Frame
Start Date: 2022-10-22
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 10
Treatments
Experimental: Sustained Dual Frequency, Dual Region, Stimulation
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov