We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motor Network Physiology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04957095
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : January 18, 2023
Sponsor:
Collaborators:
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Nader Pouratian, University of Texas Southwestern Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Parkinson Disease Essential Tremor Drug: Inbrija Other: Subcortical Stimulation

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Motor Network Physiology Characterization During Deep Brain Stimulation Surgery
Actual Study Start Date : February 18, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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: 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
Essential Tremor patients
This group consists of essential tremor patients who are undergoing deep brain stimulation for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation. Stimulation will be applied at the previously determined therapeutic frequency.
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. cortical ECoG and subcortical recordings [ Time Frame: baseline ]
    Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments and/or Inbrija administration.

  2. Behavioral assessment [ Time Frame: baseline ]
    Each patient will complete a task that assesses the kinematics of movement, self-initiation of movement, and/or effect of Inbrija on movement


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Study participants are Parkinson's disease and essential tremor patients undergoing deep brain stimulation for management of their movement disorder.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04957095


Contacts
Layout table for location contacts
Contact: Nader Pouratian, MD, PhD (214)645-5465 nader.pouratian@utsouthwestern.edu
Contact: Emily Koenig, BA 2146455465 emily.koenig@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Emily Koenig       emily.koenig@utsouthwestern.edu   
Contact: Nader Pouratian       nader.pouratian@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Nader Pouratian, MD, PhD University of Texas Southwestern Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nader Pouratian, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04957095    
Other Study ID Numbers: STU-2021-0376
1R01NS097782-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Nader Pouratian, University of Texas Southwestern Medical Center:
deep brain stimulation
levodopa medication
motor cortex
basal ganglia
thalamus
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs