Actively Recruiting
Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
Led by University of Alabama at Birmingham · Updated on 2025-10-15
36
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Clinically definite, advanced idiopathic Parkinson Disease with at least 2 of 3 cardinal features (tremor, rigidity, bradykinesia)
- Parkinson Disease duration of 4 years or more
- Participant has chosen awake DBS surgery with recommended target in STN or GPi
- Dual-target STN and GPi implantation considered appropriate and safe by neurosurgery for those opting for it
- Participant is healthy enough for surgery and study procedures
- Normal or nearly normal preoperative brain MRI except mild abnormalities from advanced PD
- Willing and able to cooperate during awake DBS surgery and post-operative evaluations
- Participant's insurance or Medicare covers DBS surgery as routine care
- Refractory motor symptoms causing significant disability despite medical management
- Stable Parkinson Disease medication doses for at least 28 days before baseline
- Improvement of motor signs by 30% or more with dopaminergic medication, or typical PD features without levodopa use due to side effects
- Disease severity above Hoehn and Yahr stage 2.5
- Activities of daily living score above 6 in worst "off" medication condition or mild-to-moderate social/occupational impairment
- Dementia Rating Scale-2 score of 130 or higher on medications
- Beck Depression Inventory II score of 25 or lower on medications
- No suicidal ideation or active suicidal thoughts
- Participant understands consent, protocol, available for follow-up, and signs informed consent
You will not qualify if you...
- Age under 18 years
- Insurance does not cover investigational device surgery (for some aims)
- Medical contraindications such as uncontrolled hypertension, heart disease, coagulopathy
- Parkinson Disease duration less than 4 years
- Clinical suspicion of needing contralateral DBS within 1 year of unilateral surgery
- Atypical parkinsonism or drug-induced parkinsonism or other significant neurological disease
- Psychogenic movement disorder diagnosis
- Dual-target implant unsafe due to anatomic or vascular reasons
- DBS placement under general anesthesia without awake testing
- Beck Depression Inventory II score above 25 or history of suicide attempt
- Suicidal ideation or planning
- Current acute psychosis, alcohol or drug abuse
- Clinical dementia with Dementia Rating Scale score below 130
- Untreated impulse control disorder
- Use of anticoagulants that cannot be stopped perioperatively
- History of hemorrhagic stroke
- Immunocompromise increasing infection risk
- History of recurrent or unprovoked seizures
- Lack of clear levodopa responsiveness
- Presence of implanted devices like pacemaker or cochlear implant
- Prior DBS surgery or ablation in affected basal ganglion
- Prior DBS surgery on opposite brain side (for some aims)
- Need or likely need for diathermy
- Structural brain lesions causing movement disorder
- Any medical or psychological issues interfering with study completion
- Female who is breastfeeding or of child-bearing potential with positive pregnancy test or inadequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
H
Harrison Walker, MD
CONTACT
C
Christopher Gonzalez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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