Attention Deficit DisorderNCT05354232
Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
A study testing 2 mA transcranial direct current stimulation (tDCS) and 1 mA transcranial direct current stimulation (tDCS) in people with Attention Deficit Disorder and Attention Deficit Disorder With Hyperactivity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- 2 mA transcranial direct current stimulation (tDCS) and 1 mA transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
DNN Inbox, 6177268780, mghdnn@mgh.harvard.edu
About this study
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.
Read the detailed description
This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.
- Being tested
- 2 mA transcranial direct current stimulation (tDCS), 1 mA transcranial direct current stimulation (tDCS), Sham transcranial direct current stimulation (tDCS)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 2mA transcranial direct current stimulation | Experimental | Not described Receives: Device: 2 mA transcranial direct current stimulation (tDCS) |
| 1mA transcranial direct current stimulation | Experimental | Not described Receives: Device: 1 mA transcranial direct current stimulation (tDCS) |
| Sham transcranial direct current stimulation | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 1 - Week 8 of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jul 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized during the first study visit to the 2mA, 1mA, or sham conditions. Subjects will not change dose throughout study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan Camprodon, MD, PHD, MPH, Principal investigator, MGB: Division of Neuropsychiatry and Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354232
- Sponsor's protocol ID
- 2022P000362
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2022
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD for the current study available to other researchers.
Publications
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.
PubMed 32327965
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05354232
- Acronym / sponsor ID
- 2022P000362
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tDCS, and its relationship to physiological target engagement. It will also provide critical knowledge about tDCS dosing in a therapeutic context (i.e. 30 days of daily tDCS). Last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD. An additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for ADHD, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized during the first study visit to the 2mA, 1mA, or sham conditions. Subjects will not change dose throughout study.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 mA transcranial direct current stimulation (tDCS)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. | Device | 2mA transcranial direct current stimulation |
| 1 mA transcranial direct current stimulation (tDCS)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. | Device | 1mA transcranial direct current stimulation |
| Sham transcranial direct current stimulation (tDCS)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. | Device | Sham transcranial direct current stimulation |
Primary outcome
P300 Amplitude during Erickson Flanker Task
Time frame: Week 1 - Week 8 of Study
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.
Global Assessment of Functioning (GAF) Scale
Time frame: Week 1 - Week 8 of Study
investigators will use GAF scale to assess the potential feasibility of at-home tDCS for future research.
Adult ADHD Self-Report Scale
Time frame: Week 1 - Week 8 of Study
Investigators will assess changes to these questionnaires in reference to assigned stimulation group to assess changes to ADHD symptomatology across study duration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 32327965Dubreuil-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.
- Individual participant dataSharing planned: No. There is no plan to make IPD for the current study available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan Camprodon, MD, PHD, MPH principal investigator
MGB: Division of Neuropsychiatry and Neuromodulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 mA transcranial direct current stimulation (tDCS) and 1 mA transcranial direct current stimulation (tDCS) in people with Attention Deficit Disorder and Attention Deficit Disorder With Hyperactivity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DNN Inbox (6177265348, mghdnn@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P300 Amplitude during Erickson Flanker Task (time frame: Week 1 - Week 8 of Study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.