Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT04735458

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease

Study Details

Brief summary:

The purpose of this study is to investigate the brain activity associated with non-motor symptoms of movement disorders, including Parkinson's disease and essential tremor. These movement disorders commonly have significant non-motor features also, including depression, cognitive impairment, decreased attention, and slower processing speeds. The investigators are interested in the brain activity associated with these symptoms, and perform recordings of the surface of the brain, in addition to the typical recordings the investigators perform, during routine deep brain stimulation (DBS) surgery.

Conditions

Parkinson Disease

Study ID

NCT04735458

Start date

Apr 1, 2021

Status verified date

Nov, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eligible for surgery based on multi-disciplinary consensus review
  • Have a diagnosis of Parkinson's disease or Essential Tremor
  • Have a diagnosis of medically-refractory movement disorder (Parkinson's disease, Essential Tremor, or dystonia)
  • Willingness to participate in the paradigms described in the protocol

Exclusion Criteria:

  • Inability to provide full and informed consent
  • Age younger than 18
  • Are not able to participate in study-related activities
  • History of prior ischemic/hemorrhagic stroke, subdural hemorrhage, or seizure

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Parkinson's Disease Patients receiving DBS electrodes

no intervention: Control

Control subjects will be non-Parkinson's Disease patients with essential tremor

Interventions

Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease

After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.

Primary outcome measure

  • Accuracy via Simon Task (% correct) [ Time Frame: Baseline ]
  • Response times via Simon Task (sec) [ Time Frame: Baseline ]
  • Simon Effect on Response times (sec) [ Time Frame: Baseline ]
  • Simon Effect on Accuracy (% correct) [ Time Frame: Baseline ]
  • United Parkinson's disease Rating Scale part 3: Motor Examination Score 0-108 (Higher score represents worse symptoms) [ Time Frame: Baseline ]
  • Dementia Rating Scale Score 0-144 points (Higher score represents better symptoms) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Nicole Bentley, MD

205-975-0011jbentley@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Nicole Bentley, MD

205-975-0011jbentley@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-02.