Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS.
- Who it may be relevant to
- Registry conditions: Attention-Deficit/Hyperactivity Disorder (ADHD). Basic parameters: 9 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Device rTMS
Repetitive transcranial magnetic stimulation (rTMS)
Primary outcome measures
- TEACH-2 [Time frame: Baseline to week 5]
Secondary outcome measures (2)
- SNAP-18 [Time frame: 5 weeks and 52 weeks.]
- PedsQL [Time frame: Baseline to week 5]
Eligibility criteria
Inclusion criteria
- Diagnosis of ADHD
- 9-15 years old
- IQ greater than 80
- English fluency (to enable consent/assent)
- If on medication, must have been on the same type and dosage for at least 3 months.
Exclusion criteria
- Diagnosis of mania, psychosis, or bipolar disorder
- Impediments to TMS or MRI (i.e. metal implants in body)
- Prior electroconvulsive therapy or vagus nerve stimulation
- Diagnosis of Autism Spectrum Disorder.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Alberta Children's Hospital — Calgary
Identifiers
NCT: NCT04532190 · REB20-1415