Network Control TMS fMRI

NCT05736458 | Terminated Results FDA Device

• 2 other identifiers: 830174RF1MH116920
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; Working Memory

Keywords

TMS; memory; ADHD; healthy; MRI; ADD

Outcome Measures

Primary Outcomes (3)

• Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance

  Control participants complete two visits in which they undergo functional MRI interleaved with TMS targeting a specific controllability region. Each visit involves administering single pulses of TMS while participants perform a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high regional controllability target and the other stimulating a low regional controllability target. The effect of single-pulse TMS on N-back task performance will be assessed before rTMS administration using percent accuracy scores. Percent accuracy reflects the percentage of correct trials out of the total Nback trials, with higher scores indicating better task performance.

  Up to 3 weeks

• Effect of rTMS on Working Memory Task Performance

  Control participants complete two visits with functional MRI interleaved with TMS targeting a specific controllability region. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted controllability region is counterbalanced, with one visit stimulating a high controllability target and the other a low controllability target. The effect of rTMS on N-back task performance will be assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy, indicating the percentage of correct trials, will be analyzed for both high and low regional controllability targets across the visits.

  Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)

• Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance

  Control participants complete two visits where they undergo functional MRI interleaved with TMS targeting specific brain controllability regions. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high controllability target and the other a low controllability target. In order to compare the effect of rTMS to high versus low controllability targets on working memory performance, we will assess the change in N-back task percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS to both regions. A greater percent change (positive value) means improved task performance following rTMS.

  Up to 3 weeks

Secondary Outcomes (1)

• Effect of rTMS on Working Memory Performance in Participants With ADHD

  Pre- and post-TMS at visit 3 (approximately day 7)

Study Arms (3)

High regional controllability TMS target in non-symptomatic participants

EXPERIMENTAL

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); Procedure: High controllability TMS target

Low controllability TMS target in non-symptomatic participants

ACTIVE COMPARATOR

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)

High regional controllability TMS target in ADHD participants

EXPERIMENTAL

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); Procedure: High controllability TMS target

Interventions

Transcranial Magnetic Stimulation (TMS) 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; High regional controllability TMS target in non-symptomatic participants; Low controllability TMS target in non-symptomatic participants

High controllability TMS target PROCEDURE

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

High regional controllability TMS target in ADHD participants; High regional controllability TMS target in non-symptomatic participants

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Enrollment goals were not completed due to delays resulting from COVID and not being granted a second no-cost extension.

Results Point of Contact

• Title: Dr. Desmond Oathes, Principal Investigator
• Organization: University of Pennsylvania

oathes@pennmedicine.upenn.edu

215-573-9390

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will use a single-blind design.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 21, 2023
• Study Start: March 25, 2019
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-01

Locations

US (1)