NCT04247334

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
Last Updated

June 8, 2026

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

January 24, 2020

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • fMRI connectivity at rest

    Changes in resting state connectivity of the inhibitory control information

    2 weeks

  • fMRI connectivity during a stop signal task

    Changes in task-based connectivity on the stop signal task

    2 weeks

Study Arms (3)

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.

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.

Device: Transcranial direct current stimulation

Interventions

20 minutes of 2 milliamp transcranial direct current stimulation

Impulsive Participants- Active StimulationImpulsive Participants- Sham Stimulation

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 30, 2020

Study Start

November 14, 2019

Primary Completion

February 25, 2024

Study Completion

February 25, 2024

Last Updated

June 8, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations