Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT04957095

Conditions

Parkinson Disease

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Apomorphine Injectable Solution

Subcortical Stimulation

Study Details

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.

Conditions

Parkinson Disease

Essential Tremor

Study ID

NCT04957095

Start date

Feb 18, 2022

Status verified date

Aug, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Apomorphine Injectable Solution

Apomorphine injected for therapeutic relief

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

Primary outcome measure

  • cortical ECoG and subcortical recordings [ Time Frame: baseline ]
  • Behavioral assessment [ Time Frame: baseline ]

Central Contacts and Locations

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 22, 2026

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-22.