- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04532190
Finding Alternatives to Standard Treatment for Attention-Deficit Hyperactivity Disorder (FAST-ADHD)
Study Overview
Status
Intervention / Treatment
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:
- Baseline Assessment (MRI Scan, assessment scales, neuropsychological testing)
- rTMS intervention: 5 / week for 4 weeks.
- Post-intervention Assessment (MRI Scan, assessment scales, neuropsychological testing).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Recruiting
- Alberta Children's Hospital
-
Contact:
- Kara r Murias, MD/PhD
- Phone Number: 1 403-441-8411
- Email: krmarten@ucalgary.ca
-
Contact:
- Kara Murias
- Email: brainkids@ucalgary.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active rTMS
Active repetitive TMS
|
Repetitive transcranial magnetic stimulation (rTMS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TEACH-2
Time Frame: Baseline to week 5
|
Test of everyday attention in children - 2. Direct assessment of attention abilities in children.
|
Baseline to week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SNAP-18
Time Frame: 5 weeks and 52 weeks.
|
Parent reporting of ADHD symptom severity
|
5 weeks and 52 weeks.
|
|
PedsQL
Time Frame: Baseline to week 5
|
Self reporting of quality of life
|
Baseline to week 5
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB20-1415
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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