Network Control TMS fMRI

University of Pennsylvania

Status: Terminated

Conditions: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Working Memory

Treatments: Procedure: High controllability TMS target; Device: Transcranial Magnetic Stimulation (TMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05736458

830174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 3 patient groups

High regional controllability TMS target in non-symptomatic participants

Experimental group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Procedure: High controllability TMS target

Low controllability TMS target in non-symptomatic participants

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

High regional controllability TMS target in ADHD participants

Experimental group

Description:

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

Treatment:

Device: Transcranial Magnetic Stimulation (TMS)

Procedure: High controllability TMS target