Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder

NCT ID: NCT04532190

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2027-12-31

Brief Summary

Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. Here, we will test if theta burst repetitive transcranial magnetic stimulation (rTMS) can reduce the symptoms of ADHD.

Detailed Description

Background & Rationale Attention-Deficit/Hyperactivity Disorder (ADHD) is characterized by poor attention, impulsivity, hyperactivity and emotional-motivational dysregulation. It has an estimated prevalence of 5% in children. Usually, ADHD in children is treated with stimulant medications, such as methylphenidate. However, these pharmacotherapy treatments have numerous unwanted side effects, including sleep disturbances, appetite changes, and emotional lability, and do not prove to be effective in every case.

A promising and alternative option for reducing ADHD symptoms is non-invasive brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive brain stimulation which involves the application of a magnetic field to the skull to change the behaviour and function of underlying brain areas. In turn, rTMS leads to positive long-term changes in neurochemical activity, and while studies are limited, some have shown that rTMS can reduce ADHD symptoms in adolescents with ADHD.

Methods Design: Open label TMS trial Primary Outcome: To examine the effect of active rTMS to the right prefrontal cortex on attention as measured by the TEACh-2

Outline:

1. Baseline Assessment (MRI Scan, assessment scales, neuropsychological testing)

2. rTMS intervention: 5 / week for 4 weeks.

3. Post-intervention Assessment (MRI Scan, assessment scales, neuropsychological testing).

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active rTMS

Active repetitive TMS

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

Repetitive transcranial magnetic stimulation (rTMS)

Interventions

rTMS

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of ADHD

2. 9-15 years old

3. IQ greater than 80

4. English fluency (to enable consent/assent)

5. If on medication, must have been on the same type and dosage for at least 3 months.

Exclusion Criteria

1. Diagnosis of mania, psychosis, or bipolar disorder

2. Impediments to TMS or MRI (i.e. metal implants in body)

3. Prior electroconvulsive therapy or vagus nerve stimulation

4. Diagnosis of Autism Spectrum Disorder.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Kara Murias

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB20-1415

Identifier Type: -

Identifier Source: org_study_id