Brain STimulation for ANxiety and Depression in Youth (Brain STAND)

January 28, 2026 updated by: Kara Murias, University of Calgary

Brain STimulation for ANxiety and Depression in Youth: Brain STAND

In this open-label trial, the overall aim is to determine if TMS treatment can improve anxiety and depression in a broad group of children and youth referred by physicians.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mental health disorders are a leading cause of disability, and approximately 14% of adolescents are diagnosed globally. Within Canada, the prevalence of mental health disorders is increasing, with youth aged 15-24 years being greatly impacted. Broadly, mental health disorders include anxiety, post-traumatic stress disorders, depression, schizophrenia, disruptive behaviour, and neurodevelopmental disorders such as autism spectrum disorder (ASD), and attention-deficit/hyperactivity disorder (ADHD). Mental health disorders are associated with clinically significant disrupted behaviour, emotional regulation, and thinking, and can limit one's ability to participate in activities of daily living and drastically impact quality of life. Moreover, a variety of negative outcomes can be associated with these mental health disorders, including health and development-related concerns regarding educational achievement, substance abuse, violence, reproductive and sexual health. In Canada, suicide was the fourth leading cause of death in children (age 1-14; after cancer, accidental injuries and congenital malformations) and the second leading cause of death in youth (age 15-19; after accidental injury) in 2023 according to Stats Can. https://www150.statcan.gc.ca/.

The literature suggests the peak age of mental health disorder onset within the general global population is 14.5 years; a recent meta-analysis of 192 epidemiological studies also reported approximately 83% of individuals with neurodevelopmental disorders experienced onset by the age of 18 years. Further, approximately 52% of individuals with anxiety or fear-related disorders, 48% with feeding or eating disorders or problems, 45% with obsessive-compulsive or related disorders, 28% with stress disorders, and 12% with mood disorders experienced onset by the age of 18 years. The high prevalence of mental health disorders within the child and youth population, and the limited options and availability of therapy choices is contributing to the need to explore additional treatment opportunities.

Interventions for mental health disorders commonly include psycho-social and pharmacological approaches, though these therapies are largely modelled after adult populations, with some indication that medications are not as effective in children and adolescents. Pharmacotherapy may be accompanied by side-effects, and adverse experiences with psychotropic medications at a young age reportedly contribute to poor long-term adherence to other psychiatric therapies. Many families and patients have strong preference for nonpharmaceutical treatments, which can limit options. Another proposed intervention strategy for mental health disorders involves non-invasive brain stimulation, including transcranial magnetic stimulation (TMS). TMS elicits changes in neural population activation with the use of repetitive TMS (rTMS) or theta-burst stimulation. TMS has been used for the treatment of anxiety and depression in adults, and both TMS and TBS have been well-tolerated in children, with only mild transient side effects noted. TMS may be an effective adjunct or sole treatment for mental health disorders in youth; for example, when combined with antidepressants, rTMS increased the treatment effect in 8-24-year-olds with depression, and therefore the clinical application of TMS for mental health disorders in youth requires further investigation. In the United States, rTMS has been approved for the treatment of depression in adolescents starting at the age of 15, and there are encouraging results in implementation studies in other jurisdictions. To ensure adolescents in Canada have access to this therapy, clinical care pathways (such as appropriate referral criteria, outcome measures, and resource requirements) must be better understood.

There are indications that TMS is effective and safe in many populations that are at high risk of depression. For example, TMS has shown to be safe and effective for treatment of depression during pregnancy. In contrast, the use of antidepressants during pregnancy is associated with a risk (though low) of adverse effects for both mother and fetus. Furthermore, treatment of anxiety and depression in complex populations with co-occurring conditions, such as in patients with neurodevelopmental disorders, has limited research in general and in neurostimulations specifically. Despite the recent approval in the United States, evidence for neurostimulation in children and adolescents is lagging behind that of adults. Given the burden of disease in this population, improvement in research, particularly implementation and clinical integration, is both a clinical and ethical imperative.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged between 6 and 18 years old
  2. diagnosis of anxiety or depression made by a qualified medical professional
  3. active anxiety and/or depression symptoms

Exclusion Criteria:

  1. status epilepticus in past 12-months
  2. presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator may compromise, interfere, limit, affect, or reduce the participant's ability to complete the study
  3. hospitalization for suicide attempt within the past 3 months (unless participant is under the daily supervision of a physician, such as in a mental health day treatment program)
  4. TMS-related contraindications, including implanted medical devices (e.g., pacemaker)
  5. if actively taking prescription medication, no changes in medication for at least 3 months prior to entry into the study, with no anticipation of change in the frequency or dose over the duration of the study, unless changes to medication are required for participant safety
  6. unable to understand instructions in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Transcranial Magnetic Stimulation (TMS)
Open-label study with active TMS for treatment.
Procedure: Transcranial Magnetic Stimulation
Participants will receive TMS for treatment measures as determined by referral and presentation.
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Children Anxiety and Depression Scale (RCADS)
Time Frame: Baseline and 5 weeks.
This 47-item questionnaire assesses the presence and severity of anxiety and depression symptoms. Items are rated from 0 (never) to 3 (always) and includes six subscales, with higher total scores indicating greater severity of symptoms.
Baseline and 5 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Global Assessment Scale (CGAS)
Time Frame: Baseline and 5 weeks.
This physician-rated scale assesses medical history, symptoms, behaviour, and psychosocial circumstances to determine level of general functioning. A score is entered from 100 (superior functioning) to 0 (needs constant supervision).
Baseline and 5 weeks.
PROMIS Pain Interference-8a
Time Frame: Baseline and 5 weeks.
This 8-item questionnaire assesses the impact of pain on aspects of daily living in the past 7 days. Items are rated from 0 (never) to 4 (almost always), with higher scores indicating pain has a greater impact on activities of daily life.
Baseline and 5 weeks.
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Baseline and 5 weeks
This 28-item questionnaire assesses health-related quality of life in the past month. This tool evaluates multiple domains, including physical, emotional, social, and school functioning. Items are rated from 0 (never) to 4 (almost always), with lower scores indicating greater quality of life.
Baseline and 5 weeks
Emotional Dysregulation Inventory (EDI) short form
Time Frame: Baseline and 5 weeks.
This 13-item questionnaire evaluates emotional dysregulation in the past 7 days. This tool is scored from 0 (not at all) to 4 (very severe), with greater scores indicating more emotional dysregulation.
Baseline and 5 weeks.
Youth Life Interference Scale (YLIS)
Time Frame: Baseline and 5 weeks.
This 11-item questionnaire assesses the impact of mental health symptoms on daily life in the past 2 weeks. Items are rated from 0 (not at all) to 4 (a great deal), with lower scores indicating mental health symptoms had less impact on daily life.
Baseline and 5 weeks.
Pubertal Development Scale (PDS)
Time Frame: Baseline
This 5-item questionnaire is used to determine an individual's puberty development category, including pre-pubertal, early pubertal, mid-pubertal, late pubertal, post-pubertal.
Baseline
Early Psychosis Screener-26 (EPS-26)
Time Frame: Baseline
This 26-item questionnaire assesses symptoms of psychosis, including hallucinations and delusions, in the past 30 days. Items are rated from 1 (never) to 5 (always), with lower scores indicating fewer symptoms of psychosis.
Baseline
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder and Normal Behaviour Scale (SWAN)
Time Frame: Baseline and 5 weeks.
This 30-item questionnaire assesses strengths and difficulties with attention and behaviour regulation. This questionnaire compares attention, activity, and impulse to others of similar age, using a scale ranging from far below to far above average.
Baseline and 5 weeks.
Aberrant Behavioural Checklist (ABC)
Time Frame: Baseline and 5 weeks.
This 58-item questionnaire assesses behaviour in the past 4 weeks, using a scale from 0 (not at all a problem) to 3 (the problem is severe in degree). This questionnaire includes 5 domains: irritability, hyperactivity, social withdrawal, stereotypic behaviour, and inappropriate speech.
Baseline and 5 weeks.
NIH Toolbox Cognition Battery
Time Frame: Baseline and 5 weeks.
This battery assesses attention, executive function, and memory and will be completed in-person on a tablet. Specifically, the List Sorting Working Memory Test, Dimension Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and Picture Sequence Memory Test will be administered and take less than 20 minutes to complete.
Baseline and 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Kara Murias, MD/PhD, The University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB25-0288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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