Sensory Filtering in the Human Basal Ganglia as a Mechanism of Parkinson's Disease

NCT05482126 | Recruiting

• 2 other identifiers: IRB-300008936R01NS124563
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are investigating the brain activity associated with sensory information in movement disorders in order to improve treatment of these symptoms beyond what is currently available.

Conditions

Parkinson Disease

Keywords

Parkinson; Sensory Processing; Basal Ganglia; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (5)

• Kinematic response to stimulus (intraoperative)

  Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.

  Intraoperative

• Kinematic response to stimulus (postoperative)

  Arm movements (hand position, velocity) recorded following stimulus onset, measured by joystick outputs.

  1 month post-op

• Latency of response to stimulus (intraoperative)

  Time from stimulus onset to start of motor response, measured by electromyography (EMG)

  Intraoperative

• Latency of response to stimulus (postoperative)

  Time from stimulus onset to start of motor response, measured by electromyography (EMG)

  1 month post-op

• Neural response to stimulus

  Brain activity recorded following stimulus onset, measured by local field potentials recorded from the electrocorticography (ECoG) and DBS electrodes.

  Intraoperative

Study Arms (2)

Deep Brain Stimulation Surgery Patients

The investigators will seek to enroll people with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical

Diagnostic Test: Intraoperative Behavioral Testing; Diagnostic Test: Behavioral Testing

Healthy controls

The investigators will seek to enroll a cohort of age- and sex-matched healthy individuals to act as a control group. This group will NOT undergo DBS surgery

Diagnostic Test: Behavioral Testing

Interventions

Intraoperative Behavioral Testing DIAGNOSTIC_TEST

During DBS surgery, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.

Deep Brain Stimulation Surgery Patients

Behavioral Testing DIAGNOSTIC_TEST

In the lab, tasks will be administered via a tablet PC or mounted monitor, and the subject may hold a response box, joystick, or dynamometer to record responses. During task periods, sensory stimuli will be delivered to the participant, who may be asked to perform a motor behavior in response. Stimuli will consist of audiovisual cues presented on a computer screen, vibration applied to specific parts of the body via a tactor, mild electrical pulses delivered through the skin of specific parts of the body via the attached EMG electrodes, and/or a movement of the arm or joint. Motor responses will consist of simple movements such as finger-tapping or hand-opening, or use of a joystick or dynamometer to move a computer cursor on the screen. Participants may be asked to respond only to a particular sensory stimulus and ignore others, in order to modulate the relevance of each stimulus to the task.

Deep Brain Stimulation Surgery Patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease (PD) who have been approved for deep brain stimulation surgery (DBS) as part of their routine clinical care, as well as healthy controls with no known movement disorder diagnoses

You may qualify if:

• Age \>18 years
• Clinically definite, advanced idiopathic PD based on consensus criteria.
• Normal, or essentially normal, preoperative brain MRI.
• Patient is available for follow-up visits over the length of the study
• Patient has elected to undergo DBS surgery as part of routine care, and subthalamic nucleus (STN) is determined as the appropriate surgical target
• Age \>18 years.
• No diagnosis of PD, other movement disorder, or other significant neurological disease.

You may not qualify if:

• Age \<18 years.
• Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions that might increase the risk of surgery
• Diagnosis or suspicion of atypical Parkinsonism (PSP, MSA, CBD) or drug-induced Parkinsonism, or significant neurological disease other than PD.
• Diagnosis of psychogenic movement disorder based on consensus criteria
• Prior DBS surgery or ablation
• Clinical dementia and/or Dementia Rating Scale (DRS) score of \<5th percentile adjusted for age and education level, based upon routine pre-op NP testing.
• Unable to withhold dopaminergic medications for at least 12 hours prior to scheduled visit
• Age \<18 years.
• Previous diagnosis of PD, other movement disorder, or other significant neurological disease.

Sponsors & Collaborators

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

Study Sites (1)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Zachary Irwin, PhD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary Irwin, PhD

CONTACT

(205) 934-6704; zirwin@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 1, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)