Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder (FAST-ADHD)

University of Calgary

Status: Not yet enrolling

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04532190

REB20-1415

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 9 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active rTMS

Experimental group

Description:

Active repetitive TMS

Treatment:

Device: rTMS