- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759898
Direct Measurement of Motor Cortical Responses to tDCS
April 10, 2026 updated by: Medical University of South Carolina
Direct Measurement of Motor Cortical Responses to Transcranial Direct Current Stimulation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with parkinson's disease
Description
Inclusion Criteria:
- Age 18 or older
- Previous consent to be contacted regarding potential participation in a research study at Medical University of South Carolina
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS
Time Frame: Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported.
|
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.
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Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nathan C Rowland, MD,PhD, 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)
January 1, 2021
Primary Completion (Actual)
January 1, 2025
Study Completion (Actual)
January 1, 2025
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
February 15, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 10, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- 00073545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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