Attention Deficit Hyperactivity DisorderNCT05736458
Network Control TMS fMRI
A study testing Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Attention Deficit Disorder, Working Memory
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Network Control and Functional Context: Mechanisms for TMS Response
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.
Read the 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.
- Being tested
- Transcranial Magnetic Stimulation (TMS), High controllability TMS target
- Keywords
- TMS, memory, ADHD, healthy, MRI, ADD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 controllability TMS targetProcedure or surgery
Administer TMS to a brain regions with high regional controllability while the subject engages in a working memory task.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Transcranial Magnetic Stimulation (TMS); Procedure: High controllability TMS target |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 weeks
Secondary outcomes (1)
Effect of rTMS on Working Memory Performance in Participants With ADHD
Participants with ADHD complete a single visit where they undergo functional MRI interleaved with TMS to a high controllability region. During the visit, participants receive single pulses of TMS while performing the 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 effect of rTMS on N-back task performance is assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy reflects the percentage of correct trials out of the total number of N-back trials, with higher percent accuracy indicating better performance.
Measured: Pre- and post-TMS at visit 3 (approximately day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start25 Mar 2019
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Why it stopped: The study was terminated because our funding agency, the NIH, did not grant a no-cost extension to meet our recruitment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736458
- Sponsor's protocol ID
- 830174
- Other IDs
- RF1MH116920
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2023
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Control and Functional Context: Mechanisms for TMS Response
- ClinicalTrials.gov ID
- NCT05736458
- Acronym / sponsor ID
- 830174
- Keywords
- TMS, memory, ADHD, healthy, MRI, ADD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because our funding agency, the NIH, did not grant a no-cost extension to meet our recruitment goals.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| High regional controllability TMS target in non-symptomatic participants | Experimental | Device: Transcranial Magnetic Stimulation (TMS), Procedure: High controllability TMS targetWe will administer TMS to an individualized target of high regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner. |
| Low controllability TMS target in non-symptomatic participants | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)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. |
| High regional controllability TMS target in ADHD participants | Experimental | Device: Transcranial Magnetic Stimulation (TMS), Procedure: High controllability TMS targetWe will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 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 targetAdminister TMS to a brain regions with high regional controllability while the subject engages in a working memory task. | Procedure or surgery | High regional controllability TMS target in ADHD participants, High regional controllability TMS target in non-symptomatic participants |
Primary outcome
Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance
Time frame: Up to 3 weeks
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.
Effect of rTMS on Working Memory Task Performance
Time frame: Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)
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.
Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance
Time frame: Up to 3 weeks
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.
1 secondary outcome
Effect of rTMS on Working Memory Performance in Participants With ADHD
Time frame: Pre- and post-TMS at visit 3 (approximately day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance (time frame: Up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.