rTMS for ADHD

(FAST-ADHD Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Mania, Psychosis, Bipolar, Autism, 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: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive treatment using magnetic fields, can reduce symptoms of ADHD. ADHD often involves challenges with focus, impulsiveness, and hyperactivity. The trial seeks participants diagnosed with ADHD, aged 10 to 15, who have been stable on any ADHD medication for at least three months. Those who meet these criteria and struggle with ADHD symptoms may find this trial a valuable opportunity to explore a new treatment option. As an unphased trial, it offers a unique chance to contribute to pioneering research in ADHD treatment.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, but you must have been on the same type and dosage for at least 3 months before joining.

What prior data suggests that rTMS is safe for ADHD?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for treating ADHD. Studies have demonstrated improvements in symptoms like inattention and hyperactivity, with only minor side effects. These side effects may include headaches or scalp discomfort, but they are usually not serious.

The evidence supporting rTMS suggests that most people tolerate it well. Although this trial is labeled "Not Applicable," indicating it might lack the detailed safety data of more advanced trials, existing research and past studies provide some confidence about its safety. Prospective participants may find this information helpful in understanding what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rTMS for ADHD because it offers a non-invasive, drug-free approach to managing symptoms. Unlike traditional treatments like stimulant medications that target neurotransmitter levels, rTMS works by using magnetic fields to stimulate specific areas of the brain involved in attention and behavior. This mechanism could potentially lead to fewer side effects and offer an alternative for individuals who do not respond well to medication. Additionally, rTMS holds promise for quicker results, providing relief in a shorter timeframe compared to some existing treatments.

What evidence suggests that rTMS might be an effective treatment for ADHD?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial will receive, can significantly improve symptoms in people with ADHD. A study that combined results from multiple research papers found that rTMS notably reduced ADHD symptoms, especially when targeting specific brain areas. Another review confirmed that rTMS can enhance thinking skills, aiding attention and focus in individuals with ADHD. Overall, these studies suggest that rTMS is a promising treatment for managing ADHD symptoms by improving attention and reducing impulsivity. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 8-16 with ADHD, an IQ over 80, and stable on current medication for at least 3 months. They must speak English to give consent. It's not suitable for those with autism, bipolar disorder, psychosis, mania or a history of certain brain treatments or metal implants.

Inclusion Criteria

I have been diagnosed with ADHD.

I am between 8 and 16 years old.

You have an IQ higher than 80.

Exclusion Criteria

I have had electroconvulsive therapy or vagus nerve stimulation before.

You have metal implants in your body that would make it difficult to do TMS or MRI.

I have been diagnosed with Autism Spectrum Disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

MRI Scan, assessment scales, neuropsychological testing

1 week

1 visit (in-person)

rTMS Intervention

Participants receive rTMS treatment 5 times a week for 4 weeks

4 weeks

20 visits (in-person)

Post-intervention Assessment

MRI Scan, assessment scales, neuropsychological testing

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview The study is examining the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in reducing ADHD symptoms compared to standard treatment options.

How Is the Trial Designed?

Group I: Active rTMS Experimental Treatment 1 Intervention

Active repetitive TMS

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

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 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) 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) 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) 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 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]

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) has a good overall safety profile for treating depression, with common side effects like headaches being minor and manageable.

While there is a low incidence of serious side effects such as seizures and hypomania, these are linked to specific risk factors, suggesting that proper screening can enhance patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Loo, CK., McFarquhar, TF., Mitchell, PB.[2021]

Citations

1. 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 ...

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05261-2

A meta-analysis on the therapeutic efficacy of repetitive ... Therapeutic efficacies of repetitive transcranial magnetic stimulation (rTMS) for improving cognitive functions in patients with ...

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

The therapeutic role of repetitive transcranial magnetic ... This study concluded that dTMS is an effective and feasible technique that may improve attention symptoms in adults with ADHD [27]. Also, the ...

6. 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.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39829146/

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06389864?cond=ADHD&aggFilters=status:not%20rec,ages:child&viewType=Table&rank=2

rTMS in Children and Adolescents With ADHD: Sixty children with ADHD of both sexes and ages ranging between 8 and 16 years old were included in the study.