Clinical trial NCT06892847: Brain STimulation for ANxiety and Depression in Youth
Official title: Brain STimulation for ANxiety and Depression in Youth: Brain STAND
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The literature suggests the peak age of mental 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. This high prevalence of mental disorders within the child and youth population is contributing to the need to explore additional treatment opportunities.

Interventions for mental disorders commonly include psycho-social and pharmacological approaches, though these therapies are largely modelled after adult populations. However, pharmacotherapy may be accompanied by side-effects, and adverse experiences with psychotropic medications at a young age may contribute to poor long-term adherence to other psychiatric therapies. Another proposed intervention strategy for mental disorders involves non-invasive brain stimulation, including transcranial magnetic stimulation (TMS). TMS can be used to measure neurophysiology or a cortical area or be used to elicit changes in neural population activation with the use of repetitive TMS (rTMS) or theta-burst stimulation (TBS). Both TMS and TBS have been well-tolerated in children, with only mild transient side effects noted, and has been approved for use in adolescents by the FDA. This study will evaluate the feasibility and acceptability of TMS in a broad group of referred children and adolescents.

Eligibility criteria: Inclusion Criteria:

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

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;
4. TMS-related contraindications, including implanted medical devices (e.g., pacemaker), metallic implants excluding non-ferromagnetic metals (e.g., metal dental wires), current pregnancy;
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.

Primary outcomes:
measure: RCADS
timeFrame: Baseline and 5 weeks.
Secondary outcomes:
measure: CGAS
timeFrame: baseline and 5 weeks.
Other outcomes:
Locations:
Study officials:
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