Motor Network Physiology

Parkinson Disease Clinical Trial

Official title:

Motor Network Physiology Characterization During Deep Brain Stimulation Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957095
• Other study ID #: STU-2021-0376
• Secondary ID: 1R01NS097782-01A
• Status: Recruiting
• Start date: February 18, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Nader Pouratian, MD, PhD
• Phone: (214)645-5465
• Email: nader.pouratian[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Parkinson's disease or Essential Tremor 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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease

Intervention

Drug:
• Inbrija
Inbrija will be administered to Parkinson's disease patients only. Patients will receive 2 capsules (84 mg) of medication.

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

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Neurological Disorders and Stroke (NINDS), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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