Young AdultsNCT04247334
Inhibitory Control: Effects of Modulation
A study testing Transcranial direct current stimulation in people with Young Adults, run by Butler Hospital at 1 site in United States.
Trial summary
Inhibitory control is relevant to many clinical disorders, including substance abuse/dependence, obsessive-compulsive disorder, and attention-deficit hyperactivity disorder. This proposal is designed to assess brain networks related to response inhibition in healthy young adults, and use neuromodulation to change… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Adults
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2019to 25 Feb 2024
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low (<1sd below the mean on the BRIEF-Inhibit) or high (>1sd above the mean on BRIEF-Inhibit scale)
- English fluency to ensure comprehension of study measures and instructions.
Who cannot join
- Presence of medical conditions contraindicated for tDCS, including history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or women of childbearing age not using effective contraception, or any other serious medical conditions or health problems that would interfere with participation (e.g., skin condition)
- Inability to undergo MRI
- Current substance abuse disorder
- Currently prescribed psychiatric medications.
- Active mania or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Circuitry of Inhibitory Control: Effects of Modulation
Inhibitory control is relevant to many clinical disorders, including substance abuse/dependence, obsessive-compulsive disorder, and attention-deficit hyperactivity disorder. This proposal is designed to assess brain networks related to response inhibition in healthy young adults, and use neuromodulation to change these networks and behavioral performance on a response inhibition task. Having an understanding of the brain mechanisms involved in response inhibition may enable us to improve pre-existing treatments for disorders with inhibitory control difficulties.
- Conditions
- Young Adults
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
20 minutes of 2 milliamp transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Cautious Participants | No intervention | Participants who have low scores on a self-report of inhibitory control abilities (BRIEF-Inhibit). |
| Impulsive Participants- Active Stimulation | Experimental | Participants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to active stimulation. Receives: Device: Transcranial direct current stimulation |
| Impulsive Participants- Sham Stimulation | Sham comparator | Participants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to sham stimulation. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI connectivity at rest
Changes in resting state connectivity of the inhibitory control information
Measured: 2 weeks
fMRI connectivity during a stop signal task
Changes in task-based connectivity on the stop signal task
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start14 Nov 2019
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young AdultsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247334
- Sponsor's protocol ID
- 1352651-9
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Circuitry of Inhibitory Control: Effects of Modulation
- ClinicalTrials.gov ID
- NCT04247334
- Acronym / sponsor ID
- 1352651-9
- Conditions
- Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 30 Jan 2020 (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.
Inhibitory control is relevant to many clinical disorders, including substance abuse/dependence, obsessive-compulsive disorder, and attention-deficit hyperactivity disorder. This proposal is designed to assess brain networks related to response inhibition in healthy young adults, and use neuromodulation to change these networks and behavioral performance on a response inhibition task. Having an understanding of the brain mechanisms involved in response inhibition may enable us to improve pre-existing treatments for disorders with inhibitory control difficulties.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cautious Participants | No intervention | –Participants who have low scores on a self-report of inhibitory control abilities (BRIEF-Inhibit). |
| Impulsive Participants- Active Stimulation | Experimental | Device: Transcranial direct current stimulationParticipants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to active stimulation. |
| Impulsive Participants- Sham Stimulation | Sham comparator | Device: Transcranial direct current stimulationParticipants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to sham stimulation. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Low (<1sd below the mean on the BRIEF-Inhibit) or high (>1sd above the mean on BRIEF-Inhibit scale)
- English fluency to ensure comprehension of study measures and instructions.
Key exclusion criteria (5 listed)
- Presence of medical conditions contraindicated for tDCS, including history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or women of childbearing age not using effective contraception, or any other serious medical conditions or health problems that would interfere with participation (e.g., skin condition)
- Inability to undergo MRI
- Current substance abuse disorder
- Currently prescribed psychiatric medications.
- Active mania or psychosis
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 stimulation20 minutes of 2 milliamp transcranial direct current stimulation | Device | Impulsive Participants- Active Stimulation, Impulsive Participants- Sham Stimulation |
Primary outcome
fMRI connectivity at rest
Time frame: 2 weeks
Changes in resting state connectivity of the inhibitory control information
fMRI connectivity during a stop signal task
Time frame: 2 weeks
Changes in task-based connectivity on the stop signal task
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 8 Jun 2026.
- 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.
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?
A study testing Transcranial direct current stimulation in people with Young Adults, run by Butler 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: finished, as of the sponsor's last update on 8 Jun 2026. 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?
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?
fMRI connectivity at rest (time frame: 2 weeks). The study lists 2 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 8 Jun 2026.