Network Control TMS fMRI

NCT ID: NCT05736458

Last Updated: 2025-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2023-07-30

Brief Summary

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This study uses different types of functional magnetic resonance imagining (fMRI) to generate individual transcranial magnetic stimulation (TMS) targets. During the TMS/fMRI imagining sessions, the investigators stimulate a target of either high or low regional controllability during a working memory task to investigate network responses and the impact of TMS on behavior.

Detailed Description

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This study involves up to 4 visits for patients with Attention Deficit Hyperactivity Disorder (ADHD) and 5 visits for non-symptomatic subjects.

Visit 1 has both remote and in-person procedures. The remote part of visit 1 will consist of a consenting and extended screening visit. The in-person procedures of visit 1 will be scheduled for the same day as visit 2. Before visit 2, the investigators will demonstrate TMS to make sure participants can tolerate the stimulation.

Visit 2 consists of an hour-long baseline MRI Scan along with an assessment session. The baseline MRI scan is used to find individualized TMS targets. The assessment session of visit 2 will be done over a video call. During the video call, the investigators will have the participant complete some computerized tasks and assessments.

Visit 3 will be a 1-hour long TMS/fMRI session, where the participant will complete a working memory task twice while single pulse TMS is being delivered. In between the 2 rounds of the working memory task, the participant will receive 4 minutes of repetitive stimulation.

Non-symptomatic subjects will have a fourth visit that mirrors visit 3.

Visit 5 or Visit 4 for ADHD participants, will take place if behavioral task is available, otherwise study participation will be considered complete. During the optional visit, participants may complete behavioral tasks during an MRI scan. No TMS will be administered during the final visit.

Participants will receive the compensation at the end of their participation. Payment may be given earlier if the participant withdraws from the study.

Conditions

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Attention Deficit Hyperactivity Disorder Attention Deficit Disorder Working Memory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All healthy participants will have TMS administered to both their high and low regional controllability targets, but the order is randomized and counterbalanced.

ADHD participants will have TMS administered to only their high regional controllability target.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
This study will use a single-blind design.

Study Groups

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High regional controllability TMS target in non-symptomatic participants

We will administer TMS to an individualized target of high regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.

High controllability TMS target

Intervention Type PROCEDURE

Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.

Low controllability TMS target in non-symptomatic participants

We will administer TMS to an individualized target of low regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.

High regional controllability TMS target in ADHD participants

We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type DEVICE

Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.

High controllability TMS target

Intervention Type PROCEDURE

Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.

Interventions

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Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication.

Intervention Type DEVICE

High controllability TMS target

Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-28 years old
* Right-handed
* No history of schizophrenia or bipolar disorder
* No history of neurological illness
* Healthy participants: no history of any mental illness
* ADD/ADHD Participants; Diagnosed with ADD/ADHD
* ADD/ADHD: Ability to refrain from stimulant medication within 24 hours of study sessions
* For participants reporting daily use of more than 400mg caffeine/ day: willing to lower down to this level at least 1 week prior to screening visit and maintain throughout study visits

Exclusion Criteria

* Unable to have an MRI scan
* Unable to receive or tolerate TMS
* Pregnant, nursing, or trying to become pregnant (self-attestation alone)
* History of stoke, epilepsy, or brain scarring
* Healthy participants: psychoactive medication use
* Healthy participants: first degree relative with psychosis
* ADHD participants: inability to refrain from stimulant medication within 23 hours of study sessions
* Active suicidality or current suicidal risk as determined by the investigator
* Any medication that interferes with fMRI recordings as per PI discretion
* Otherwise determined by investigator to be unfit for study
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RF1MH116920

Identifier Type: NIH

Identifier Source: secondary_id

View Link

830174

Identifier Type: -

Identifier Source: org_study_id

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