Clinical trial NCT05736458: Network Control TMS fMRI
Official title: Network Control and Functional Context: Mechanisms for TMS Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Attention Deficit Disorder
Working Memory
Keywords: TMS
memory
ADHD
healthy
MRI
ADD
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2023-02-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance
timeFrame: Up to 3 weeks
measure: Effect of rTMS on Working Memory Task Performance
timeFrame: Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)
measure: Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Effect of rTMS on Working Memory Performance in Participants With ADHD
timeFrame: Pre- and post-TMS at visit 3 (approximately day 7)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: