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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a treatment using magnetic pulses to stimulate the brain can reduce ADHD symptoms in children and adolescents. It targets those who may not respond well to traditional treatments. The magnetic pulses aim to improve brain function related to attention and behavior. This non-invasive brain stimulation tool has potential for broad application in individuals with neuropsychiatric conditions, including ADHD.

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 data supports the effectiveness of the treatment rTMS for ADHD?

Some studies suggest that repetitive transcranial magnetic stimulation (rTMS) may help improve symptoms of ADHD, such as hyperactivity and attention difficulties, with effects lasting several weeks. However, results are mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is rTMS safe for use in humans?

Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe when used within recommended guidelines, with common side effects being minor, such as headaches. There is a low risk of seizures, which can be minimized by screening for risk factors, and long-term effects are still being studied. ^{1 6 7 8 9}

How does rTMS treatment for ADHD differ from other treatments?

rTMS (Repetitive Transcranial Magnetic Stimulation) is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, particularly the prefrontal cortex, which is thought to be underactive in ADHD. Unlike traditional medications, rTMS does not involve drugs and may help improve attention and reduce hyperactivity by modulating brain activity, offering a potential alternative for those who may not respond well to medication. ^{1 2 3 4 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

References

1. England 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. Croatia pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS): new tool, new therapy and new hope for ADHD. [2008]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

8. Ireland 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A functional magnetic resonance imaging investigation of prefrontal cortex deep transcranial magnetic stimulation efficacy in adults with attention deficit/hyperactive disorder: A double blind, randomized clinical trial. [2023]