Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.

August 18, 2025 updated by: Medical University of South Carolina
The purpose of this study is to better understand how subdural electrical stimulation of the brain affects motor cortical oscillations

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Direct cortical stimulation (DCS) has shown the potential to improve symptoms in patients with Parkinson's disease, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how DCS affects motor areas in the brain. Investigators propose using subdural DCS (sDCS) while simultaneously recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. Investigators expect this novel approach to broaden our understanding of sDCS application and possibly lead to therapeutic advances in this population.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with PD and consented and scheduled for DBS surgery with the PI
  • Age 18-80

Exclusion Criteria:

  • Patients unable to actively participate in the consent process physically and/or cognitively
  • Previous adverse reaction to Keppra (levetiracetam)
  • Prior intracranial surgery with the exception of deep brain stimulation surgery
  • Prior brain radiotherapy
  • Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation
  • Prior history of seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects will undergo stimulation with the device
Device: Direct cortical stimulation
Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of arm movements in 60 seconds
Time Frame: 60 seconds
Number of arm movements in 60 seconds
60 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Nathan Rowland, M.D., Ph.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2025

Primary Completion (Actual)

August 16, 2025

Study Completion (Actual)

August 16, 2025

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

July 16, 2025

First Posted (Actual)

July 25, 2025

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00142103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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