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Network Control TMS fMRI

Primary Purpose

Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Working Memory

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
High controllability TMS target
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring TMS, memory, ADHD, healthy, MRI, ADD

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

High regional controllability TMS target in non-symptomatic participants

Low controllability TMS target in non-symptomatic participants

High regional controllability TMS target in ADHD participants

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
January 19, 2023
Last Updated
February 10, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05736458
Brief Title
Network Control TMS fMRI
Official Title
Network Control Transcranial Magnetic Stimulation (TMS) Functional Magnetic Resonance Imaging (fMRI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Working Memory
Keywords
TMS, memory, ADHD, healthy, MRI, ADD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
This study will use a single-blind design.
Allocation
Non-Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High regional controllability TMS target in non-symptomatic participants
Arm Type
Experimental
Arm 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.
Arm Title
Low controllability TMS target in non-symptomatic participants
Arm Type
Active Comparator
Arm 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.
Arm Title
High regional controllability TMS target in ADHD participants
Arm Type
Experimental
Arm Description
We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
High controllability TMS target
Intervention Description
Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.
Primary Outcome Measure Information:
Title
Effect of TMS to a high regional controllability target vs TMS to a low regional controllability target on Nback task performance
Description
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.
Time Frame
Up to 3 weeks
Secondary Outcome Measure Information:
Title
Change in Nback task performance after rTMS
Description
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.
Time Frame
Single visit (~2 hours)
Title
Change in Nback task performance after rTMS to a high regional controllability target - ADHD/ADD patients
Description
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.
Time Frame
Single visit (~2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille Blaine
Phone
215-746-3512
Email
camille.blaine@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Almaris Figueroa-Gonzalez
Phone
215-746-6751
Email
almaris.figueroa-gonzalez@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille Blaine
Phone
215-746-3512
Email
camille.blaine@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Almaris Figueroa-Gonzalez
Phone
215-746-6751
Email
almaris.figueroa-gonzalez@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Desmond Oathes

12. IPD Sharing Statement

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Network Control TMS fMRI

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