TMS for ADHD
Recruiting in Palo Alto (17 mi)
Overseen BySteve W Wu, M.D.
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.
12345Is 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.
14678How 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.
12349Eligibility 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)
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Active repetitive TMSActive Control1 Intervention
Group II: Sham repetitive TMSPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
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Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
References
Randomised sham-controlled study of high-frequency bilateral deep transcranial magnetic stimulation (dTMS) to treat adult attention hyperactive disorder (ADHD): Negative results. [2022]Recent studies support the possible effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for attention deficit hyperactivity disorder (ADHD). The objective of this study was to evaluate the safety and possible efficacy of bilateral prefrontal deep rTMS for the treatment of adult ADHD.
Effectiveness of the repetitive Transcranical Magnetic Stimulation (rTMS) of 1 Hz for Attention-Deficit Hyperactivity Disorder (ADHD). [2022]ADHD it is a syndrome characterized by the progressive development of excessive hyperactivity, impulsiveness and attentional difficulties. The purpose of our study is to verify the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (low frequency (1Hz, 1200 stim/die for five days)), applied on the impending scalp additional motor area, in a subject affected by ADHD. Results show a significant improvement that lasted for at least 4 weeks. Placebo control did not show any improvement.
Additional biological therapies for attention-deficit hyperactivity disorder: repetitive transcranical magnetic stimulation of 1 Hz helps to reduce methylphenidate. [2022]Excessive hyperactivity, impulsiveness and attentional difficulties characterize attention-deficit hyperactivity disorder (ADHD). The aim of this case report is to signal the possible therapeutic effectiveness of the repetitive transcranial magnetic stimulation (rTMS). Low frequency (1Hz, 1200 stim/die for five days) was applied on the impending scalp in the motor additional area of a patient suffering from combined type ADHD who received methylphenidate (MPH). We saw a significant improvement, especially according to criteria associated with hyperactivity. The improvement lasted for at least three weeks and suggested the final reduction in dosage of MPH.to 10 mg.
Transcranial magnetic stimulation (TMS) in the treatment of attention-deficit/hyperactivity disorder in adolescents and young adults: a pilot study. [2022]Transcranial magnetic stimulation (TMS) uses a medical device that applies magnetic pulses noninvasively to the cortex of the brain to depolarize neurons. We tested its safety and efficacy in young persons with a diagnosis of attention-deficit/hyperactivity disorder (ADHD).
Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. [2022]Repetitive transcranial stimulation (rTMS) affects dopaminergic secretion in the prefrontal cortex. Attention deficit hyperactivity disorder (ADHD) had been suggested to involve dopaminergic prefrontal abnormalities.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.
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]Single-pulse transcranial magnetic stimulation (TMS) is a safe and useful tool for investigating various aspects of human neurophysiology, particularly corticospinal function, in health and disease. Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes. Although there is evidence that rTMS is useful for treating clinical depression, and possibly other brain disorders, it had caused 7 known seizures by 1996 and could have other undesirable effects. In June 1996 a workshop was organized to review the available data on the safety of rTMS and to develop guidelines for its safe use. This article summarizes the workshop's deliberations. In addition to issues of risk and safety, it also addresses the principles and applications of rTMS, nomenclature, and potential therapeutic effects of rTMS. The guidelines for the use of rTMS, which are summarized in an appendix, cover the ethical issues, recommended limits on stimulation parameters, monitoring of subjects (both physiologically and neuropsychologically), expertise and function of the rTMS team, medical and psychosocial management of induced seizures, and contra-indications to rTMS.
Image-guided TMS is safe in a predominately pediatric clinical population. [2022]The safety of transcranial magnetic stimulation (TMS) has been previously evaluated in healthy volunteers and clinical adult populations. We sought to fill the gap in safety of TMS functional mapping in a clinical, predominately pediatric cohort.
Noninvasive brain stimulation in children and adults with attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. [2021]Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) could provide treatment alternatives to stimulant medication for attention-deficit/hyperactivity disorder (ADHD), given some evidence for improvements in cognition and clinical symptoms. However, despite a lack of solid evidence for their use, rTMS and tDCS are already offered clinically and commercially in ADHD. This systematic review and meta-analysis aimed to critically appraise rTMS and tDCS studies in ADHD to inform good research and clinical practice.