TMS for ADHD

Overseen By Karlee Migneault, B.A.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Non-stimulants, Antipsychotics

Disqualifiers: Epilepsy, Brain injury, Depression, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.

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 data supports the effectiveness of the treatment TMS for ADHD?

Some studies suggest that repetitive transcranial magnetic stimulation (rTMS) can 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 repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in both healthy individuals and those with various brain conditions. While generally considered safe, it has been associated with some risks, such as seizures, and guidelines have been developed to minimize these risks. Safety guidelines have been updated over the years, with the most recent in 2021, to ensure safe application in clinical settings. ^{1 4 6 7 8}

How is repetitive transcranial magnetic stimulation (rTMS) different from other treatments for ADHD?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it uses magnetic pulses to stimulate specific areas of the brain noninvasively, unlike traditional ADHD treatments that often involve medication. This method may help reduce symptoms like hyperactivity and impulsiveness and can potentially lower the dosage of medications like methylphenidate. ^{1 2 3 4 9}

Research Team

Steve W Wu, M.D.

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Active repetitive TMS (Behavioural Intervention)
• Sham repetitive TMS (Behavioural Intervention)

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.

Participant Groups

Group I: Active repetitive TMS Active Control 1 Intervention

Group II: Sham repetitive TMS Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

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) 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]

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]

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) 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 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]

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]

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. Croatia pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. United States 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. [2022]

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

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

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

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

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. Canada pubmed.ncbi.nlm.nih.gov

Noninvasive brain stimulation in children and adults with attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. [2021]