Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06169852
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Unilateral dual-target (STN/GPi) DBS — DEVICE
    Participants will be randomly assigned either DBS stimulation in the STN alone, GPi alone, or a combination of stimulation in the STN and GPi.

Study Details

Our goal is to better understand how DBS modifies local neuronal activity and to pioneer device technologies that can record local DBS-evoked potentials (DLEPs) to guide therapy. Our vision is for a patient's unique electrophysiology to guide both electrode targeting during surgery and programming in clinic, eventually as an integrated component of the implanted pulse generator. Our results will inform directional DBS for PD and serve as a model for translation to other diseases where knowledge on DBS circuit interactions is at an even earlier stage.

Key Dates

Start date
Jan 12, 2024
Status verified
Oct 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Arm 1 (0-4 months)
    In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi.
  • Experimental: Arm 2 (4-8 months)
    In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arm 1.
  • Experimental: Arm 3 (8-12 months)
    In this arm we will stimulate from either STN alone, GPi alone, or a combination of both STN and GPi, whichever was not used in Arms 1 and 2.

Primary Outcome Measure

Validate the biological origin of brain signals using an external stimulation/recording system during standard of care Deep Brain Stimulation surgery, both awake and under general anesthesia. [ Time Frame: At standard of care DBS surgery (awake) and approximately one week later at standard of care battery placement (under general anesthesia). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Christopher Gonzalez
[email protected]
205-975-3732
Harrison Walker, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Alabama at Birmingham· Birmingham, AL

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