Individualizing tDCS Dose

Motor Function Clinical Trial

Official title:

Testing the Effects of Individualized and 4mA tDCS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742439
• Other study ID #: 00104712
• Secondary ID: P2CHD086844
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: Mark S George
• Phone: 8437929888
• Email: georgem[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Function
• tDCS

Intervention

Device:
• 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.
• Individualized transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).
• 2mA transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.
• 4mA transcranial direct current stimulation
Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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