Motor Network Physiology

Motor Network Physiology Characterization During Deep Brain Stimulation Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Essential Tremor
• Intervention / Treatment: Drug: Apomorphine Injectable Solution; Other: Subcortical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nader Pouratian, MD, PhD; Phone Number: (214)645-5465; Email: nader.pouratian@utsouthwestern.edu
• Study Contact Backup: Name: Sachil Chilukuri; Phone Number: 2146455465; Email: sahil.chilukuri@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Nader Pouratian; Email: nader.pouratian@utsouthwestern.edu
      • Contact: Sahil Chilukuri; Email: sahil.chilukuri@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Parkinson's disease patients; 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; Apomorphine injected for therapeutic relief; Other: Subcortical Stimulation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: University of California, Los Angeles; National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Nader Pouratian, MD, PhD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: deep brain stimulation; motor cortex; basal ganglia; thalamus; levodopa medication
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Essential Tremor
• Other Study ID Numbers: STU-2021-0376; 1R01NS097782-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No