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Individualizing tDCS Dose

NCT ID: NCT04742439

Last Updated: 2025-11-06

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WITHDRAWN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

2024-12-02

Study Completion Date

2024-12-02

Brief Summary

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Transcranial direct current stimulation (tDCS) is a noninvasive method of modulating brain activity and has therapeutic potential in many neurological and psychiatric conditions. However, unlike every current FDA-approved form of brain stimulation, there is no method of individualizing stimulation dose. In this study, a method of individualizing tDCS dose on behavioral outcomes and whether this could help to improve the consistency and magnitude of the stimulation effects will be tested.

Detailed Description

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Conditions

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tDCS Motor Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sham stimulation

Group Type SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type DEVICE

Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.

Individualized stimulation

Group Type EXPERIMENTAL

Individualized transcranial direct current stimulation

Intervention Type DEVICE

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).

2mA stimulation

Group Type EXPERIMENTAL

2mA transcranial direct current stimulation

Intervention Type DEVICE

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.

4mA stimulation

Group Type EXPERIMENTAL

4mA transcranial direct current stimulation

Intervention Type DEVICE

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.

Interventions

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Sham transcranial direct current stimulation

Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.

Intervention Type DEVICE

Individualized transcranial direct current stimulation

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).

Intervention Type DEVICE

2mA transcranial direct current stimulation

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.

Intervention Type DEVICE

4mA transcranial direct current stimulation

Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers or chronic stroke participants (at least 6 months prior to the study)
* No history of epilepsy
* No metal in the body
* No contraindications for TMS or MRI scanning
* Right handed
* Ability to find motor hotspot and acquire motor evoked potentials

Exclusion Criteria

* Metal in the body
* History of epilepsy or claustrophobia
* Alcohol or substance abuse or dependence
* Current treatment for any psychiatric conditions (pharmacological or otherwise)
* Pregnant or actively breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Kevin Caulfield

Research Assistant Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark S George, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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P2CHD086844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00104712

Identifier Type: -

Identifier Source: org_study_id