Investigating Inhibitory Control Networks in Parkinson's Disease

NCT04735458 | Recruiting

• 2 other identifiers: IRB3000036051K23NS117735-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Accuracy via Simon Task (% correct)

  In the Simon task, participants are instructed to respond with a right or left button press (Right = Red, Left = Blue) according to how a word is printed on a screen ("RED" or "BLUE"), regardless of the color in which the word is printed. This is a measurement of accuracy (% correct, ranging from 0-100, with higher scores indicating better performance)

  Baseline

• Response times via Simon Task (sec)

  In the Simon task, participants are instructed to respond with a right or left button press according to the word "RIGHT" or "LEFT" that appears on a screen, regardless of where on the screen it actually appears. This is a measurement response times (continuous measure, from 0-4000 milliseconds) between correct and incorrect responses.

  Baseline

• Simon Effect on Response times (sec)

  Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in response times between congruent and incongruent trials

  Baseline

• Simon Effect on Accuracy (% correct)

  Participants will perform the Simon task as described, and the Simon effect will be calculated as the difference in accuracy between congruent and incongruent trials

  Baseline

• United Parkinson's disease Rating Scale part 3: Motor Examination Score 0-108 (Higher score represents worse symptoms)

  Participants will undergo motor evaluation using the validated United Parkinson's disease Rating Scale (UPDRS) part 3.

  Baseline

• Dementia Rating Scale Score 0-144 points (Higher score represents better symptoms)

  Participants will undergo neuropsychological testing as part of routine care, including the Dementia Rating Scale

  Baseline

Study Arms (2)

Treatment

EXPERIMENTAL

Parkinson's Disease Patients receiving DBS electrodes

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

Control

NO INTERVENTION

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 OTHER

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Nicole Bentley, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Bentley, MD

CONTACT

205-975-0011; jbentley@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)