Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.

NCT ID: NCT07084792

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-16

Study Completion Date

2025-08-16

Brief Summary

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The purpose of this study is to better understand how subdural electrical stimulation of the brain affects motor cortical oscillations

Detailed Description

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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.

Conditions

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Parkinsons Disease (PD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Subjects will undergo stimulation with the device

Group Type EXPERIMENTAL

Direct cortical stimulation

Intervention Type DEVICE

Stimulation

Interventions

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Direct cortical stimulation

Stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathan Rowland, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

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Pro00142103

Identifier Type: -

Identifier Source: org_study_id

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