NCT07084792

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2025

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

August 16, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

June 17, 2025

Last Update Submit

August 18, 2025

Conditions

Parkinsons Disease (PD)

Keywords

Parkinsons

Outcome Measures

Primary Outcomes (1)

  • Number of arm movements in 60 seconds

    Number of arm movements in 60 seconds

    60 seconds

Study Arms (1)

Subjects will undergo stimulation with the device

EXPERIMENTAL
Device: Direct cortical stimulation

Interventions

Direct cortical stimulationDEVICE

Stimulation

Subjects will undergo stimulation with the device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nathan Rowland, M.D., Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

July 25, 2025

Study Start

August 16, 2025

Primary Completion

August 16, 2025

Study Completion

August 16, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08