Attention Deficit Hyperactivity DisorderNCT04175028
Neuromodulation of Executive Function in the ADHD Brain
A study testing Transcranial Direct Current Stimulation in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 18-66 years of age
- Healthy volunteers or volunteers with a diagnosis of ADHD in adulthood, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [American Psychiatric Association, 2013] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
- Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
- English-speaking
Who cannot join
- Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
- Pregnant or nursing females.
- Inability to participate in testing procedures
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- Additional exclusion criteria for healthy controls:
- Diagnosis of psychiatric of neurological disorder
- Ongoing treatment with any psychotropic medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.
Read the detailed description
This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD. Deficits in these cognitive functions are core to ADHD, and cause significant impairment and morbidity. The study will also include a cohort of healthy controls for comparison.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Executive Function
- 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.
Transcranial Direct Current StimulationDevice
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Other | Patients with ADHD. Receives: Device: Transcranial Direct Current Stimulation |
| Healthy Control | Other | Volunteers without Neuropsychiatric Disorders. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accuracy and Reaction Time in Attention and Working Memory
N-Back Task
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Change in Accuracy and Reaction Time in Attention and Working Memory
Flanker Task
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Change in Accuracy and Reaction Time in Attention and Working Memory
Multi-Source Interference with International Affective Picture System Task
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Delayed Discounting
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Stop Signal Task
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Cambridge Gambling Task
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Secondary outcomes (1)
Amplitude of Encephalogram (EEG) Event Related Potentials
Measure of amplitude related to stimulus
Measured: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study startSep 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
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 Hyperactivity 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
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, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175028
- Sponsor's protocol ID
- 2014P001401
- Status last verified
- Mar 2024
- First submitted
- 18 Nov 2019
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.
PubMed 33549516
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
- Neuromodulation of Executive Function in the ADHD Brain
- ClinicalTrials.gov ID
- NCT04175028
- Acronym / sponsor ID
- 2014P001401
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 22 Nov 2019 (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.
This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.
Detailed description
This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD. Deficits in these cognitive functions are core to ADHD, and cause significant impairment and morbidity. The study will also include a cohort of healthy controls for comparison.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | Other | Device: Transcranial Direct Current StimulationPatients with ADHD. |
| Healthy Control | Other | Device: Transcranial Direct Current StimulationVolunteers without Neuropsychiatric Disorders. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects 18-66 years of age
- Healthy volunteers or volunteers with a diagnosis of ADHD in adulthood, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [American Psychiatric Association, 2013] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
- Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
- English-speaking
Key exclusion criteria (7 listed)
- Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
- Pregnant or nursing females.
- Inability to participate in testing procedures
- Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
- Additional exclusion criteria for healthy controls:
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 |
|---|---|---|
| Transcranial Direct Current StimulationIn tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes. | Device | ADHD, Healthy Control |
Primary outcome
Change in Accuracy and Reaction Time in Attention and Working Memory
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
N-Back Task
Change in Accuracy and Reaction Time in Attention and Working Memory
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Flanker Task
Change in Accuracy and Reaction Time in Attention and Working Memory
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Multi-Source Interference with International Affective Picture System Task
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Delayed Discounting
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Stop Signal Task
Change in Accuracy and Reaction Time in Inhibition/Decision Making
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Cambridge Gambling Task
1 secondary outcome
Amplitude of Encephalogram (EEG) Event Related Potentials
Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 33549516Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joan Camprodon, MD, PhD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Attention Deficit Hyperactivity Disorder, 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 4 inclusion and 7 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: finished, 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Accuracy and Reaction Time in Attention and Working Memory (time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks). The study lists 6 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 NCT04175028, 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.