Direct Measurement of Motor Cortical Responses to tDCS
1 other identifier
observational
20
1 country
1
Brief Summary
Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with movement deficits, such as Parkinson's disease and chronic stroke. However, the effects of tDCS have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tDCS works. This has limited the adoption of this potentially useful therapy for patients with Parkinson's disease, chronic stroke and other conditions affecting movement. The investigators hypothesize that by studying the effects of tDCS in subjects performing a motor task, the brain signals mediating improvements in motor control will be identified. The investigators will use both noninvasive and invasive methods to explore this hypothesis. The investigators expect this combined approach to broaden understanding of tDCS application in conditions affecting movement and possibly lead to therapeutic advances in these populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedResults Posted
Study results publicly available
May 1, 2026
CompletedMay 1, 2026
April 1, 2026
4 years
December 21, 2020
March 20, 2026
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS
Primary motor cortex (PriMC) beta-band (13-30 Hz) spectral power was measured using subdural electrocorticography (sECoG) in patients with Parkinson's disease undergoing deep brain stimulation surgery. Spectral power was analyzed during the movement preparation phase of a cued arm-reaching task. The outcome represents the change in beta-band spectral power during anodal transcranial direct current stimulation (tDCS) relative to pre-stimulation baseline, averaged across task trials for each participant.
Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported.
Study Arms (1)
Stimulation (invasive recording)
Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation
Interventions
Subjects are brought into the operating room. The scalp is prepped with a sterilizing solution. Following infiltration with local anesthetic and incision, a 6-contact electrocorticography strip is inserted into the burr hole covering primary motor cortex. Electrocorticography strip terminals are connected to an amplifier for signal recording. Gas-sterilized transcranial direct current stimulation electrodes are placed on the scalp directly overlying primary motor cortex. tDCS electrodes are connected to a low-current generator. During electrocorticographic recording, stimulation is turned on while subjects are asked to flex each arm. At the conclusion of the experiment, the electrocorticography strip and tDCS electrodes are removed and the surgery proceeds as planned.
Eligibility Criteria
patients with parkinson's disease
You may qualify if:
- Age 18 or older
- Previous consent to be contacted regarding potential participation in a research study at Medical University of South Carolina
You may not qualify if:
- Subjects unable to actively participate in the consent process physically and/or cognitively
- Pregnancy
- Presence of scalp injury or disease
- Prior history of seizures
- Metal implants in head or neck
- Prior intracranial surgery
- Prior brain radiotherapy
- Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Attending
- Organization
- Medical University of South Carolina
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan C Rowland, MD,PhD
Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2020
First Posted
February 18, 2021
Study Start
January 1, 2021
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
May 1, 2026
Results First Posted
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share