Inhibitory Control: Effects of Modulation

• Sponsor: Butler Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04247334
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 43.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Young Adults	Device: Transcranial direct current stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Brain Circuitry of Inhibitory Control: Effects of Modulation
• Actual Study Start Date: Nov 14, 2019
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. fMRI connectivity at rest [2 weeks]

   Changes in resting state connectivity of the inhibitory control information

2. fMRI connectivity during a stop signal task [2 weeks]

   Changes in task-based connectivity on the stop signal task

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Butler Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• Butler Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Butler Hospital
• ClinicalTrials.gov Identifier: NCT04247334
• Other Study ID Numbers: 1352651-9
• First Posted: Jan 30, 2020
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 9, 2021