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RecruitingNCT04957095Updated Oct 1, 2026

Motor Network Physiology

An interventional study of Apomorphine Injectable Solution and Subcortical Stimulation in Parkinson Disease and Essential Tremor, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease
  • Essential Tremor

Keywords

  • deep brain stimulation
  • levodopa medication
  • motor cortex
  • basal ganglia
  • thalamus
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with recent use (within one week) of anticoagulant or antiplatelet agents
  • Neurocognitive testing indicating amnestic cognitive deficits
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study 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.

    Drug: Apomorphine Injectable Solution · Other: Subcortical Stimulation

Interventions

  • Apomorphine injected for therapeutic relief

  • OtherSubcortical 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04957095
Responsible party
Nader Pouratian (Professor of Medicine, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jul 12, 2021
Start date
Feb 18, 2022
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Nader Pouratian, MD, PhD
Contact
nader.pouratian@utsouthwestern.edu
(214)645-5465
Sachil Chilukuri
Contact
sahil.chilukuri@utsouthwestern.edu
2146455465
Nader Pouratian, MD, PhD
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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