Individualizing tDCS Dose

Not Applicable

Withdrawn

• Conditions: tDCS; Motor Function
• Interventions: Device: 4mA transcranial direct current stimulation; Device: Individualized transcranial direct current stimulation; Device: Sham transcranial direct current stimulation; Device: 2mA transcranial direct current stimulation

• Registration Number: NCT04742439
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Status Verified: 2024-12
• Study Start: 2024-12-02
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4mA stimulation	4mA transcranial direct current stimulation	-
Individualized stimulation	Individualized transcranial direct current stimulation	-
Sham stimulation	Sham transcranial direct current stimulation	-
2mA stimulation	2mA transcranial direct current stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in Motor Evoked Potential Variance	Baseline and post-stimulation (20 minutes apart)	MEP variance is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.
Difference in Motor Evoked Potential Amplitudes from 4mA and 2mA Stimulation	Baseline and post-stimulation (20 minutes apart)	MEP amplitude is measured by single pulses of transcranial magnetic stimulation and contralateral hand electrodes.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States