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NCT Number: NCT04957095

Motor Network Physiology

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Nader Pouratian

CONTACT

[email protected]

Sahil Chilukuri

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apomorphine Injectable Solution

Drug

Apomorphine injected for therapeutic relief

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

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nader Pouratian, MD, PhD

CONTACT

[email protected]

(214)645-5465

Sachil Chilukuri

CONTACT

[email protected]

2146455465

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of California, Los Angeles

Registry information

Official study title

Motor Network Physiology Characterization During Deep Brain Stimulation Surgery

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 12, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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