Motor Network Physiology

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with recent use (within one week) of anticoagulant or antiplatelet agents

Neurocognitive testing indicating amnestic cognitive deficits

Trial design

Design model

Single group

Treatments tested in this trial

  • Apomorphine Injectable Solution

    Drug

    Apomorphine injected for therapeutic relief

  • Subcortical Stimulation

    Other intervention

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Parkinson's disease patientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline
2

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

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

University of California, Los Angeles

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator