Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)

NCT05354232 | Recruiting DMC FDA Device

• 1 other identifier: 2022P000362
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.

Conditions

Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (3)

• P300 Amplitude during Erickson Flanker Task

  P300, an electrophysiological feature theorized to represent executive functioning, has been previously shown to be notably diminished during the Erickson Flanker Task (EFT) . We will be administering this task to assess changes in P300 during the EFT, and if any changes are related to subjects' assigned condition.

  Week 1 - Week 8 of Study

• Global Assessment of Functioning (GAF) Scale

  investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research.

  Week 1 - Week 8 of Study

• Adult ADHD Self-Report Scale

  Investigators will assess changes to these questionnaires in reference to assigned stimulation group to assess changes to ADHD symptomatology across study duration.

  Week 1 - Week 8 of Study

Study Arms (3)

2mA transcranial direct current stimulation

EXPERIMENTAL

Device: 2 mA transcranial direct current stimulation (tDCS)

1mA transcranial direct current stimulation

EXPERIMENTAL

Device: 1 mA transcranial direct current stimulation (tDCS)

Sham transcranial direct current stimulation

SHAM COMPARATOR

Device: Sham transcranial direct current stimulation (tDCS)

Interventions

2 mA transcranial direct current stimulation (tDCS) DEVICE

tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 2mA condition, the investigators will assist the administration of a 2mA current stimulation from the device.

2mA transcranial direct current stimulation

1 mA transcranial direct current stimulation (tDCS) DEVICE

tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the 1mA condition, the investigators will assist the administration of a 1mA current stimulation from the device.

1mA transcranial direct current stimulation

Sham transcranial direct current stimulation (tDCS) DEVICE

tDCS is a non-invasive neuromodulatory technique that has previously demonstrated the ability to transiently modulate cognitive domains in both healthy and psychiatric populations. In the sham condition, the investigators will assist the administration of a sham stimulation from the device.

Sham transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients 18-65 years of age
• A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

You may not qualify if:

• Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
• Active substance dependence (except for tobacco).
• Pregnant or nursing females.
• Inability to participate in testing procedures.
• Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

Related Publications (1)

• Dubreuil-Vall L, Ruffini G, Camprodon JA. Deep Learning Convolutional Neural Networks Discriminate Adult ADHD From Healthy Individuals on the Basis of Event-Related Spectral EEG. Front Neurosci. 2020 Apr 9;14:251. doi: 10.3389/fnins.2020.00251. eCollection 2020.

  PMID: 32327965 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joan Camprodon, MD, PHD, MPH

  MGB: Division of Neuropsychiatry and Neuromodulation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DNN Inbox

CONTACT

6177265348; mghdnn@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Soterix devices allow for effective and automated double-blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief - Neuropsychiatry & Neuromodulation

Model Details: Subjects will be randomized during the first study visit to the 2mA, 1mA, or sham conditions. Subjects will not change dose throughout study.

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 29, 2022
• Study Start: July 1, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)