Network Control TMS fMRI

February 22, 2024 updated by: University of Pennsylvania

Network Control Transcranial Magnetic Stimulation (TMS) Functional Magnetic Resonance Imaging (fMRI)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study involves up to 4 visits for ADHD patients 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.

Study Type

Interventional

Enrollment (Actual)

45

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 Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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 28 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Procedure: High controllability TMS target
Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.
Active Comparator: 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.
Device: 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.
Experimental: 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.
Device: 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.
Procedure: High controllability TMS target
Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of TMS to a high regional controllability target vs TMS to a low regional controllability target on Nback task performance
Time Frame: Up to 3 weeks

Control subjects have two visits where they complete a working memory task (Nback) while receiving TMS. The TMS target is counterbalanced across the two visits, with one administering TMS to high regional controllability target and the other to a low regional controllability target.

Nback task performance will be determined for both high controllability and low regional controllability TMS targets using summary behavior measures, including percent accuracy. Higher percent accuracy indicates better task performance.
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nback task performance after rTMS
Time Frame: Single visit (~2 hours)

Control subjects complete two trials of a working memory task (Nback) while receiving single pulses of TMS. In between the two Nback trials, subjects receive neuromodulatory repetitive TMS (rTMS).

Change in the Nback task performance after rTMS will be determined for high and low regional controllability targets. Greater positive change indicates better task performance after rTMS.
Single visit (~2 hours)
Change in Nback task performance after rTMS to a high regional controllability target - ADHD/ADD patients
Time Frame: Single visit (~2 hours)

Patients with ADD/ADHD complete two trials of a working memory task (Nback) while receiving single pulses of TMS. In between the two Nback trials, subjects receive neuromodulatory repetitive TMS (rTMS).

Change in the Nback task performance after rTMS will be determined for subjects with ADHD. Greater positive change indicates better task performance after rTMS.
Single visit (~2 hours)

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

Collaborators

National Institutes of Health (NIH)

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)

March 25, 2019

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 830174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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