ADHDNCT02290899
Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
An observational study of ADHD, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- ADHD
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 7 Aug 2017
- Phase
- Observational
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with ADHD
Who may be able to join
- Clinical diagnosis of ADHD
- Parent informed consent and child assent
Who cannot join
- Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- History of head injury resulting in prolonged loss of consciousness
- Substance abuse or dependence within the past six months
- Chronic treatment with prescription medications that decrease cortical seizure threshold that the patient is unable to withhold from taking during study visits
- Damaged skin on the scalp (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Bradley Hospital
East Providence, Rhode Island, 02915
About this study
The main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.
- Conditions
- ADHD
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop-Signal Task
Measured: Immediately following tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJun 2014
- Primary completion7 Aug 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nancy Lurie Marks Family Foundation, Bradley Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290899
- Sponsor's protocol ID
- 4067-14
- Status last verified
- Apr 2017
- First submitted
- 11 Nov 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Behavioral Inhibition in Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02290899
- Acronym / sponsor ID
- 4067-14
- Conditions
- ADHD
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Nancy Lurie Marks Family Foundation, Bradley Hospital
- Study start
- Jun 2014
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 14 Nov 2014 (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 main purpose of this study is to investigate how the brain responds to a procedure known as transcranial direct current stimulation (tDCS) and how tDCS affects performance on a behavioral task. Research suggest that this procedure leads to improvement in brain and behavioral measures of inhibitory control (controlling impulses) in healthy control participants. The investigators want to explore whether the same improvement will be seen in kids with ADHD.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with ADHD
Key inclusion criteria (2 listed)
- Clinical diagnosis of ADHD
- Parent informed consent and child assent
Key exclusion criteria (8 listed)
- Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis Type 1 (NF1), tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- History of head injury resulting in prolonged loss of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stop-Signal Task
Time frame: Immediately following tDCS
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 10 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Rhode Island 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 8 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 10 Aug 2017. 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?
Stop-Signal Task (time frame: Immediately following tDCS). 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 10 Aug 2017.