What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally well-tolerated, but some patients may experience mild side effects. These can include headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles. Less commonly, patients might experience lightheadedness. Serious side effects are rare but can include seizures, particularly in individuals with epilepsy. Other neuromodulation treatments, such as vagus nerve stimulation, may cause side effects like voice changes, throat pain, or coughing. Overall, these treatments are considered safe with a low incidence of severe adverse effects.

What prior FDA approvals exist?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive neuromodulation technique that has been FDA-approved for the treatment of major depressive disorder, particularly in patients who have not responded to other treatments. While rTMS is being studied for its potential in improving self-regulation in conditions like Autism Spectrum Disorder (ASD), there are no specific FDA approvals for rTMS solely for emotional regulation. Other neuromodulation therapies, such as Electroconvulsive Therapy (ECT), have also been FDA-approved for severe depression, which indirectly affects emotional regulation. However, direct FDA approvals for treatments specifically targeting emotional regulation through neural modulation are limited.

What other types of research exist?

Promising alternatives to rTMS for emotional regulation include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. Transcutaneous supraorbital nerve stimulation has shown significant pain reduction in migraine patients, indicating its potential for modulating neural activity. Remote electrical neuromodulation, controlled via a smartphone, has also demonstrated efficacy in reducing acute migraine pain, suggesting its utility in emotional regulation.

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Device

rTMS for Autism

Phase 2

Recruiting

Led By Deryk Beal, PhD

Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria Checklist

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

Must have

Children with a diagnosis of autism spectrum disorder and self-regulation impairment or challenges

Be younger than 65 years old

Must not have

Co-existing neurological conditions (epilepsy, stroke, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 6, 18

Summary

This trial will test if using magnetic fields to stimulate the brain can help children and youth with autism manage their emotions better and reduce disruptive behaviors. The study will observe the effects over a short period to see if it works.

Who is the study for?

This trial is for children with Autism Spectrum Disorder who struggle with self-regulation. They must be able to undergo rTMS treatment safely, meaning no history of seizures, family history of seizures, metal implants in the body, or other neurological conditions like epilepsy.

What is being tested?

The study tests if repetitive Transcranial Magnetic Stimulation (rTMS) can help kids with Autism manage their emotions and behaviors better. It includes a comparison between actual rTMS and sham (fake) stimulation alongside behavioral assessments and MRI scans before and after treatment.

What are the potential side effects?

Possible side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness, or tingling. There's also a low risk of seizure but it's generally considered safe when standard guidelines are followed.

Eligibility Criteria

Inclusion Criteria

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

Select...

My child has autism and struggles with self-regulation.

Exclusion Criteria

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

Select...

I have a neurological condition like epilepsy or have had a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 6, 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 6, 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 6, 18 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adherence

Attrition

Blinding success

+1 more

Secondary study objectives

Clinical Measure of Self-Regulation: The Response To Stress Questionnaire - Family Stress

Clinical Measure of Self-regulation: Aberrant Behaviour Checklist - Irritability Subscale

Clinical Measure of Self-regulation: Emotion Dysregulation Index Reactivity and Dysphoria

+5 more

Side effects data

From 2005 Phase 2 trial • 50 Patients • NCT00004980

59%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Active Repetitive Transcanial Magnetic Stimulation

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: repetitive transcranial magnetic stimulation (rTMS)Experimental Treatment1 Intervention

Participants will receive 15 rTMS sessions for 3 weeks.

Group II: ShamPlacebo Group1 Intervention

Participants will receive 15 sessions of sham stimulation for 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

repetitive transcranial magnetic stimulation (rTMS)

2003

Completed Phase 2

~380

0 / 2Eligibility 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

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive treatment that uses magnetic fields to stimulate specific areas of the brain involved in mood regulation and executive function. By modulating neural activity in these regions, rTMS can enhance self-regulation and emotional control. This is particularly important for patients with emotional regulation issues, as it offers a targeted approach to alleviate symptoms and improve mental health outcomes.