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Motor Network Physiology

Motor Network Physiology Characterization During Deep Brain Stimulation Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04957095
Enrollment
120
Registered
2021-07-12
Start date
2022-02-18
Completion date
2028-12-01
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor, Parkinson Disease

Keywords

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

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.

Interventions

Apomorphine injected for therapeutic relief

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Basic science study of effects of therapeutic interventions on intracranial physiology

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cortical ECoG and subcortical recordingsbaselineCortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments and/or Inbrija administration.
Behavioral assessmentbaselineEach patient will complete a task that assesses the kinematics of movement, self-initiation of movement, and/or effect of Inbrija on movement

Countries

United States

Contacts

Primary ContactNader Pouratian, MD, PhD
nader.pouratian@utsouthwestern.edu(214)645-5465
Backup ContactSachil Chilukuri
sahil.chilukuri@utsouthwestern.edu2146455465

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026