Network Control TMS fMRI

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05736458
Collaborator
National Institutes of Health (NIH) (NIH)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation (TMS)
  • Procedure: High controllability TMS target
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
95 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
This study will use a single-blind design.
Primary Purpose:
Basic Science
Official Title:
Network Control Transcranial Magnetic Stimulation (TMS) Functional Magnetic Resonance Imaging (fMRI)
Actual Study Start Date :
Mar 25, 2019
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Effect of TMS to a high regional controllability target vs TMS to a low regional controllability target on Nback task performance [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.

Secondary Outcome Measures

  1. Change in Nback task performance after rTMS [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.

  2. Change in Nback task performance after rTMS to a high regional controllability target - ADHD/ADD patients [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 28 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05736458
Other Study ID Numbers:
  • 830174
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023