What side effects are associated with this type of intervention?

Common treatments for ADHD include medications like stimulants (e.g., methylphenidate and amphetamines) and non-stimulants (e.g., atomoxetine and guanfacine). Stimulants can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and anxiety. Non-stimulants may cause fatigue, dry mouth, dizziness, and mood swings. Repetitive Transcranial Magnetic Stimulation (rTMS), a neuromodulation technique being studied for ADHD, has shown side effects like lightheadedness, tingling, and tinnitus in other conditions. Overall, rTMS is generally well-tolerated with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, primarily focusing on stimulant medications such as methylphenidate (e.g., Ritalin) and amphetamines (e.g., Adderall). Non-stimulant medications like atomoxetine (Strattera) and extended-release guanfacine (Intuniv) have also been approved. These treatments differ from Repetitive Transcranial Magnetic Stimulation (rTMS), which is a non-invasive neuromodulation technique currently under investigation for its potential to improve ADHD symptoms by modulating neural activity in the brain.

What other types of research exist?

Promising, novel alternatives to rTMS for ADHD treatment include: 1) Transcranial Direct Current Stimulation (tDCS), which uses a low electrical current to modulate brain activity and has shown potential in improving cognitive functions. 2) Neurofeedback, a technique that trains individuals to regulate their brain activity through real-time feedback and has demonstrated benefits in managing ADHD symptoms. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which involves stimulating the vagus nerve to influence brain function and has shown promise in preliminary studies for various neurological conditions.

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Non-invasive Brain Stimulation

rTMS for ADHD (FAST-ADHD Trial)

N/A

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of ADHD

8-16 years old

Must not have

Prior electroconvulsive therapy or vagus nerve stimulation

Diagnosis of Autism Spectrum Disorder.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 5 (a decrease is an improvement)

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), and temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with ADHD.

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I am between 8 and 16 years old.

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I am between 8 and 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had electroconvulsive therapy or vagus nerve stimulation before.

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I have been diagnosed with Autism Spectrum Disorder.

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I have been diagnosed with post-concussive syndrome before.

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I have been diagnosed with mania, psychosis, or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 5 (a decrease is an improvement)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 5 (a decrease is an improvement)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 5 (a decrease is an improvement) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conners-3 Parent Rating Scale

Secondary study objectives

GABA Concentration

Glutamate Concentration

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active rTMSExperimental Treatment1 Intervention

Active repetitive TMS parameters will be intensity 120% resting motor threshold (RMT), 40 pulses over 4 seconds (frequency 10Hz), inter-trial interval of 26 seconds, 75 trains, 3000 pulses/session to the right superior frontal gyrus, duration of 37.5 minutes per session.

Group II: Sham rTMSPlacebo Group1 Intervention

For sham rTMS, set-up, duration, and sound (i.e. clicking sound) will be the same, but no magnetic field will be emitted from the rTMS coil.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain, enhancing attention and reducing impulsivity and hyperactivity. Non-stimulant medications, such as atomoxetine, work by selectively inhibiting the reuptake of norepinephrine. Behavioral therapies focus on modifying behavior through reinforcement techniques. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive treatment that modulates neural activity in the brain, potentially improving ADHD symptoms by targeting specific brain regions involved in attention and behavior regulation. Understanding these mechanisms is crucial for ADHD patients as it helps tailor treatments to individual needs, potentially improving outcomes and reducing symptoms.

Targeting repetitive transcranial magnetic stimulation in depression: do we really know what we are stimulating and how best to do it?Alleviation of ADHD symptoms by non-invasive right prefrontal stimulation is correlated with EEG activity.Transcranial magnetic stimulation in neurology: what we have learned from randomized controlled studies.