Inhibitory Control: Effects of Modulation

December 5, 2023 updated by: Butler Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • Butler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Low (<1sd below the mean on the BRIEF-Inhibit) or high (>1sd above the mean on BRIEF-Inhibit scale)
  2. English fluency to ensure comprehension of study measures and instructions.

Exclusion Criteria:

  1. 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)
  2. Inability to undergo MRI
  3. Current substance abuse disorder
  4. Currently prescribed psychiatric medications.
  5. Active mania or psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Cautious Participants
Participants who have low scores on a self-report of inhibitory control abilities (BRIEF-Inhibit).
Experimental: Impulsive Participants- Active Stimulation
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
20 minutes of 2 milliamp transcranial direct current stimulation
Sham Comparator: Impulsive Participants- Sham Stimulation
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
20 minutes of 2 milliamp transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fMRI connectivity at rest
Time Frame: 2 weeks
Changes in resting state connectivity of the inhibitory control information
2 weeks
fMRI connectivity during a stop signal task
Time Frame: 2 weeks
Changes in task-based connectivity on the stop signal task
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1352651-9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Young Adults

Clinical Trials on Transcranial direct current stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe