NCT04759898

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

December 21, 2020

Results QC Date

March 20, 2026

Last Update Submit

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

Device: transcranial direct current stimulation (invasive recording)

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.

Stimulation (invasive recording)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Attending
Organization
Medical University of South Carolina

Study Officials

  • Nathan C Rowland, MD,PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

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

Locations