NCT05736458

Network Control TMS fMRI

Network Control and Functional Context: Mechanisms for TMS Response

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder
• Working Memory

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-25
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2023-02-21
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study