Attention Deficit Hyperactivity DisorderNCT02640651
An Study of Transcranial Direct Current Stimulation in Adults With ADHD
A study testing DC-Stimulator (PLUS version) in people with Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- DC-Stimulator (PLUS version)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Aug 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults 18-65 years of age.
- A diagnosis of childhood onset ADHD, 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 several symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
- English-speaking.
Who cannot join
- Current or past history of mental retardation, severe sensory impairment such as deafness or blindness, hypomania, mania, psychosis, suicidal or homicidal behavior.
- Current moderate to severe symptoms of a mental health condition other than ADHD, assessed using a clinical evaluation and the Adult Self Report Scale that, in the judgment of the investigator, may jeopardize subject safety or interfere with their ability to participate in the study. Specifically, this will include current clinical diagnosis of moderate to severe major depression, or a score on the depressive problem subscale of the ASRS that falls in the clinically significant range.
- Substance use disorder within the past 6 months.
- Any significant medical condition, that, in the judgment of the investigator, may jeopardize subject safety.
- Pregnant females.
- Inability or unwillingness to participate in study procedures.
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- Contraindication to tDCS: history of epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, or pacemakers.
- Skin conditions that may make the application of, treatment with, and removal of the tDCS hardware painful as per the discretion of the clinician.
- Current use of a medication considered to be therapeutic for ADHD. If a subject is taking a medication that is considered by study investigators to potentially treat ADHD (eg. a stimulant, atomoxetine, buproprion, modafanil, serotonin-norepinephrine reuptake inhibitor, guanfacine or clonidine) they must stop use of this medication for at least 5 half lives of the drug under physician guidance prior to study participation. Subjects will not enter the study if it would require stopping a medication that is optimally and comfortably managing a clinical concern.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Open Label Pilot Study of Transcranial Direct Current Stimulation in Adults With ADHD
The purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- DC-Stimulator (PLUS version)
- 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.
DC-Stimulator (PLUS version)Device
transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| DC-Stimulator (PLUS version) | Experimental | For tDCS stimulation, anodal stimulation of the right dorsolateral prefrontal cortex will be performed for twenty minutes at 2mA. The current will be applied by a battery-driven tDCS stimulator via a pair of saline-soaked sponge electrodes (25 cm2 surface). The anodal electrode will be placed on the scalp at the F4 position according to the international 10-20 EEG coordinate system. 20 minute tDCS sessions will be conducted ten times over a two week period Receives: Device: DC-Stimulator (PLUS version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Each of the individual DSM-V symptoms of ADHD is rated 0 to 3 on a scale of severity.
Measured: Baseline to 2 weeks
Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Assesses levels of executive function deficits
Measured: Baseline to 2 weeks
Cambridge Neuropsychological Test Automated Battery (CANTAB)
A computer-based system designed to assess executive functioning
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: Lack of study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig B. Surman, MD, Massachusetts General Hospital
- Investigators
- Craig Surman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640651
- Sponsor's protocol ID
- 2014P001728
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of Transcranial Direct Current Stimulation in Adults With ADHD
- ClinicalTrials.gov ID
- NCT02640651
- Acronym / sponsor ID
- 2014P001728
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of study staff
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- 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 purpose of this pilot study is to determine whether transcranial direct current stimulation safely and effectively improves symptoms of ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC-Stimulator (PLUS version) | Experimental | Device: DC-Stimulator (PLUS version)For tDCS stimulation, anodal stimulation of the right dorsolateral prefrontal cortex will be performed for twenty minutes at 2mA. The current will be applied by a battery-driven tDCS stimulator via a pair of saline-soaked sponge electrodes (25 cm2 surface). The anodal electrode will be placed on the scalp at the F4 position according to the international 10-20 EEG coordinate system. 20 minute tDCS sessions will be conducted ten times over a two week period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female adults 18-65 years of age.
- A diagnosis of childhood onset ADHD, 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 several symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
- English-speaking.
Key exclusion criteria (9 listed)
- Current or past history of mental retardation, severe sensory impairment such as deafness or blindness, hypomania, mania, psychosis, suicidal or homicidal behavior.
- Current moderate to severe symptoms of a mental health condition other than ADHD, assessed using a clinical evaluation and the Adult Self Report Scale that, in the judgment of the investigator, may jeopardize subject safety or interfere with their ability to participate in the study. Specifically, this will include current clinical diagnosis of moderate to severe major depression, or a score on the depressive problem subscale of the ASRS that falls in the clinically significant range.
- Substance use disorder within the past 6 months.
- Any significant medical condition, that, in the judgment of the investigator, may jeopardize subject safety.
- Pregnant females.
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 |
|---|---|---|
| DC-Stimulator (PLUS version)transcranial direct current stimulation | Device | DC-Stimulator (PLUS version) |
Primary outcome
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Time frame: Baseline to 2 weeks
Each of the individual DSM-V symptoms of ADHD is rated 0 to 3 on a scale of severity.
Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)
Time frame: Baseline to 2 weeks
Assesses levels of executive function deficits
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline to 2 weeks
A computer-based system designed to assess executive functioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Craig Surman, MD 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 DC-Stimulator (PLUS version) 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 3 inclusion and 9 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: paused, as of the sponsor's last update on 15 Aug 2019. 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?
Results are not available in the source record.
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?
Adult ADHD Investigator Symptom Rating Scale (AISRS) (time frame: Baseline to 2 weeks). 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?
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 15 Aug 2019.