TMS for ADHD

Overseen By Karlee Migneault, B.A.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Non-stimulants, Antipsychotics

Disqualifiers: Epilepsy, Brain injury, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Transcranial Magnetic Stimulation (TMS) can help children with ADHD improve impulse control. TMS is a non-invasive treatment that uses magnetic fields to stimulate specific brain areas, specifically the pre-supplementary motor area, which is linked to self-control issues in ADHD. The trial compares the effects of real TMS treatment (Active repetitive TMS) with a sham (fake) treatment to determine if there are noticeable improvements in controlling actions. Children aged 12-17 with an ADHD diagnosis who can stop taking their stimulant medication 24 hours before the TMS visits might be suitable for this research. As an unphased trial, this study offers a unique opportunity to contribute to understanding new treatment options for ADHD.

Will I have to stop taking my current medications?

If you are taking stimulant medications for ADHD, you will need to stop them 24 hours before and during the days of the TMS visits. Non-stimulant ADHD medications and certain other medications are not allowed during the trial.

What prior data suggests that this TMS treatment is safe for children with ADHD?

Research has shown that Transcranial Magnetic Stimulation (TMS) is generally safe for treating ADHD. Studies have found that TMS can reduce symptoms such as inattention and hyperactivity, with only a few minor side effects. Most individuals who have tried TMS report it is easy to handle and does not cause significant discomfort or harm. Although researchers continue to study TMS for ADHD, its use in other conditions suggests it is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using repetitive transcranial magnetic stimulation (TMS) for ADHD because it offers a non-invasive way to potentially improve attention and focus. Unlike standard treatments like stimulants or behavioral therapy, TMS uses magnetic fields to stimulate nerve cells in the brain, which may help modulate brain activity associated with ADHD symptoms. This technique could provide an alternative for those who experience side effects from medication or who don't respond to traditional therapies. Additionally, TMS has the advantage of being a targeted treatment, which might reduce the risk of systemic side effects often seen with medication.

What evidence suggests that TMS is effective for ADHD?

Research has shown that Transcranial Magnetic Stimulation (TMS) can greatly improve symptoms of ADHD, such as difficulty paying attention and hyperactivity. Studies have found that TMS helps children with ADHD better control impulsive behaviors. In this trial, participants will receive either Active repetitive TMS or Sham repetitive TMS. A review of several studies found that TMS effectively reduced overall ADHD symptoms compared to a group that did not receive the treatment. This non-invasive method targets the part of the brain that controls impulses, which often functions differently in people with ADHD. Past studies have shown promising results, making TMS a potential option for managing ADHD symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Steve W Wu, M.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children aged 12-17 with ADHD. Participants can be on stimulants, but must stop them 24 hours before and during TMS visits.

Inclusion Criteria

I am between 12 and 17 years old.

I can stop using stimulants 24 hours before and during my TMS visits.

I have been diagnosed with ADHD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Cognitive testing and basic anatomic brain MRI are performed during visit 1. Baseline TMS-based physiologic measures, stop signal task, and EEG data are collected during visit 2.

1 week

2 visits (in-person)

Treatment

Two trains of Intermittent Theta Burst Stimulation (iTBS) are delivered. The first train is randomized to sham vs. active, and the second train is active for all participants. Repeat TMS-based measures, stop signal task, and EEG data are collected.

1 day

1 visit (in-person)

Follow-up

A virtual computer-based visit to assess for any potential side effects.

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Active repetitive TMS
• Sham repetitive TMS

Trial Overview The study tests if Transcranial Magnetic Stimulation (TMS) targeting the pre-SMA brain area affects self-control in ADHD patients. It compares active TMS to a sham (fake) treatment.

How Is the Trial Designed?

Group I: Active repetitive TMS Active Control 1 Intervention

Group II: Sham repetitive TMS Placebo Group 1 Intervention

Active repetitive TMS is already approved in United States, European Union for the following indications:

Approved in United States as TMS for:

• Depression
• Obsessive-Compulsive Disorder (OCD)

Approved in European Union as TMS for:

• Depression
• Obsessive-Compulsive Disorder (OCD)
• Anxiety

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) was found to be safe for young individuals with ADHD, as there were no serious adverse events or significant changes in auditory thresholds or neuropsychological assessments during the study involving 9 participants over 2 weeks.

While there was an overall improvement in ADHD symptoms as measured by the Clinical Global Impression-Improvement scale, the study did not find a significant difference in efficacy between the active TMS and sham treatment phases, suggesting that further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) in the treatment of attention-deficit/hyperactivity disorder in adolescents and young adults: a pilot study. Weaver, L., Rostain, AL., Mace, W., et al.[2022]

A systematic review of 18 studies involving 311 children and adults with ADHD found that while rTMS and tDCS showed some positive effects on cognitive functions like inhibition and processing speed, there was little evidence for significant clinical improvement in ADHD symptoms.

The meta-analysis indicated that 1 to 5 sessions of anodal tDCS primarily targeting the dorsolateral prefrontal cortex resulted in only trend-level improvements, suggesting that more extensive and well-designed studies are needed before rTMS and tDCS can be recommended as effective treatments for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation in children and adults with attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Westwood, SJ., Radua, J., Rubia, K.[2021]

In a pilot study involving 13 adults with ADHD, a single session of high-frequency rTMS to the right prefrontal cortex significantly improved attention scores shortly after treatment, indicating potential efficacy for attention enhancement in ADHD.

The study found no significant effects on mood or anxiety, and the sham rTMS showed no impact, suggesting that the observed benefits were specifically due to the real rTMS intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. Bloch, Y., Harel, EV., Aviram, S., et al.[2022]

Repetitive Transcranial Magnetic Stimulation (rTMS) at low frequency (1Hz) applied to the additional motor area of the scalp showed significant therapeutic effectiveness in improving symptoms of ADHD in the studied subject.

The improvement in ADHD symptoms lasted for at least 4 weeks, while the placebo control group did not show any improvement, indicating the potential efficacy of rTMS as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the repetitive Transcranical Magnetic Stimulation (rTMS) of 1 Hz for Attention-Deficit Hyperactivity Disorder (ADHD). Niederhofer, H.[2022]

Repetitive transcranial magnetic stimulation (rTMS) applied at low frequency (1Hz) for five days showed significant therapeutic effectiveness in reducing hyperactivity symptoms in a patient with combined type ADHD who was also taking methylphenidate (MPH).

The improvement in hyperactivity lasted for at least three weeks, suggesting that rTMS may allow for a reduction in the dosage of MPH, indicating a potential complementary treatment approach for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional biological therapies for attention-deficit hyperactivity disorder: repetitive transcranical magnetic stimulation of 1 Hz helps to reduce methylphenidate. Niederhofer, H.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

In a study involving 26 adult patients with ADHD, bilateral deep transcranial magnetic stimulation (dTMS) did not show any significant clinical benefits compared to sham treatment, indicating it may not be an effective therapy for adult ADHD.

The study highlights the need for caution in interpreting these results due to the small sample size, suggesting that further research is necessary to fully understand the potential of dTMS in treating ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised sham-controlled study of high-frequency bilateral deep transcranial magnetic stimulation (dTMS) to treat adult attention hyperactive disorder (ADHD): Negative results. Paz, Y., Friedwald, K., Levkovitz, Y., et al.[2022]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11743978/

Efficacy and Safety of Transcranial Magnetic Stimulation for ... TMS significantly improved the inattention, hyperactivity/impulsivity, and total symptom scores in ADHD patients with minor adverse events.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38593057/

A meta-analysis of randomized sham-controlled trials ... The primary outcome was overall improvement in ADHD symptoms. Subgroup analysis focused on the efficacy of rTMS in different brain regions. Secondary outcomes ...

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1544816/full

a systematic review and meta-analysis of cortical ... The “therapeutic“ meta-analysis, encompassing 8 samples from 7 studies, demonstrated that rTMS significantly improved ADHD symptoms compared to control ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03663179

Transcranial Magnetic Stimulation for Attention Deficit ... This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0890856725003399

Noninvasive Brain Stimulation in Attention-Deficit ... Meta-analyses indicated that rTMS was effective in alleviating inattention symptoms (Hedges' g = −1.44, p = .002), reducing hyperactivity/ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6263241/

Clinical effects of repetitive transcranial magnetic ... They observed that the scores of CGI-I and ADHD-IV were significantly improved after 2 weeks of treatment. Consistently, our results showed that ...

7. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-022-00210-3

The therapeutic role of repetitive transcranial magnetic ... Repetitive transcranial magnetic stimulation showed some evidence for improving symptoms of ADHD along with its relative safety, thus could ...