Motor Network Physiology

NCT04957095 | Recruiting

• 2 other identifiers: STU-2021-03761R01NS097782-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological disorders, like Parkinson's disease (PD) and essential tremor (ET), cause abnormalities in these brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases and is thought to help patients by modulating brain networks responsible for movement. Levodopa medication is also used to modulate this brain networks in patients with PD. The overall objective is to develop a unified theory of basal ganglia thalamocortical (BGTC) circuit dynamics that accounts for disease symptomatology, movement, and their inter-relationship. The underlying hypothesis, is that the rigidity and bradykinesia of PD are fundamentally related to excessive functional coupling across nodes in the BGTC motor circuit impeding effective information flow. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation, cortical stimulation, and pharmacologic therapy in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.

Conditions

Parkinson Disease; Essential Tremor

Keywords

deep brain stimulation; levodopa medication; motor cortex; basal ganglia; thalamus

Outcome Measures

Primary Outcomes (2)

• cortical ECoG and subcortical recordings

  Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments and/or Inbrija administration.

  baseline

• Behavioral assessment

  Each patient will complete a task that assesses the kinematics of movement, self-initiation of movement, and/or effect of Inbrija on movement

  baseline

Study Arms (1)

Parkinson's disease patients

EXPERIMENTAL

This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation and / or inhaled levodopa medication, Inbrija. Stimulation will be applied at the previously determined therapeutic frequency. Two capsules (84 mg) of Inbrija will be administered.

Drug: Apomorphine Injectable Solution; Other: Subcortical Stimulation

Interventions

Apomorphine Injectable Solution DRUG

Apomorphine injected for therapeutic relief

Parkinson's disease patients

Subcortical Stimulation OTHER

Subcortical simulation of the deep brain stimulation surgery target site will be applied by clinically placed deep brain stimulation electrodes at the previously determined therapeutic setting

Parkinson's disease patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease who have been recommended to undergo deep brain stimulation for management of their movement disorder
• Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
• Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes

You may not qualify if:

• Patients with recent use (within one week) of anticoagulant or antiplatelet agents
• Neurocognitive testing indicating amnestic cognitive deficits

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of California, Los Angeles: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

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

Study Officials

• Nader Pouratian, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nader Pouratian, MD, PhD

CONTACT

(214)645-5465; nader.pouratian@utsouthwestern.edu

Sachil Chilukuri

CONTACT

2146455465; sahil.chilukuri@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Basic science study of effects of therapeutic interventions on intracranial physiology

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 12, 2021
• Study Start: February 18, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)