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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: 2mA transcranial direct current stimulationExperimental treatment 1 intervention
Group B: 1mA transcranial direct current stimulationExperimental treatment 1 intervention
Group C: Sham transcranial direct current stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 1 - Week 8 of Study
2

Global Assessment of Functioning (GAF) Scale

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

Time frame
Week 1 - Week 8 of Study
3

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.

Time frame
Week 1 - Week 8 of Study

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.