Brain STimulation for ANxiety and Depression in Youth

NCT06892847 | Recruiting

• 1 other identifier: REB25-0288
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depression

Outcome Measures

Primary Outcomes (1)

• Revised Children Anxiety and Depression Scale (RCADS)

  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 Outcomes (10)

• Children's Global Assessment Scale (CGAS)

  Baseline and 5 weeks.

• PROMIS Pain Interference-8a

  Baseline and 5 weeks.

• Pediatric Quality of Life Inventory (PedsQL)

  Baseline and 5 weeks

• Emotional Dysregulation Inventory (EDI) short form

  Baseline and 5 weeks.

• Youth Life Interference Scale (YLIS)

  Baseline and 5 weeks.

Study Arms (1)

Transcranial Magnetic Stimulation (TMS)

EXPERIMENTAL

Open-label study with active TMS for treatment.

Procedure: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation PROCEDURE

Participants will receive TMS for treatment measures as determined by referral and presentation.

Also known as: TMS

Transcranial Magnetic Stimulation (TMS)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• status epilepticus in past 12-months
• 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
• 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)
• TMS-related contraindications, including implanted medical devices (e.g., pacemaker)
• 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
• unable to understand instructions in English

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kara Murias, MD/PhD

  The University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara Murias, MD/PhD

CONTACT

1 403-441-8411; krmarten@ucalgary.ca

Adrianna Guiffre, PhD

CONTACT

adrianna.giuffre1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open label

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)