rTMS Feasibility Study on Adolescent Depression Stimulation

Study Overview
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Brief Summary
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This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

Detailed Description
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The intervention follows the identical clinical procedure used for adults. Initially, the resting motor threshold will be determined by stimulation over the motor cortex, by finding the minimal intensity that produces a motor response in the corresponding distal wrist muscles. The rTMS will be delivered with a powerMAG research ppTMS stimulator (Mag & More), and a figure-of -eight coil, PMD70-pCool (Mag & More). The intervention is within the intended use of this CE-marked medical device. The research participants will receive 1Hz rTMS with daily sessions on 20-30 consecutive week days. The magnetic pulses will be applied at 120% of the resting motor threshold with a figure-of-eight coil at a 45 degree angle towards the midline. The 1Hz rTMS protocol is applied 6 trains of 1-min duration separated by 30-sec inter-train off periods over the right DLPFC (F4 site 5 according to the10-20 system). The total duration of one 1 Hz rTMS session is 8 min 30 s.

Official Title
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1 Hz rTMS Feasibility Study on Adolescent Treatment Resistant Major Depression

Conditions
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Major Depressive Disorder, Unipolar Depression, Bipolar Depression

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent from parents and legal guardian Age 13-19 years Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID) Treatment with at least two SSRIs at an adequate dose for at least 8 weeks Exclusion Criteria: Epilepsy or medical history of seizures Conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil Implanted device that is activated or controlled in any way by physiological signals Implanted medication pumps Intracardiac lines (even if removed) Active substance use disorder Treatment with any medication that could lower the threshold for seizures Usage of benzodiazepines both as prescribed drug and illegal use Any condition that seriously increases the risk of non-compliance or loss of follow-up

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* rTMS induces local electrical currents in the stimulated neurons and has been shown to induce long-term inhibition or excitation of groups of neurons in treated cortical areas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inclusion rate - | Participant inclusion during the course of the study | two years | 
| Attrition rate | Participant drop-off during the course of the study | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGAS (Children's Global Assessment Scale) score | Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning. | 4 weeks, 6 weeks | 
| MADRS (Montgomery and Asberg Depression Rating Scale) score | Montgomery and Asberg Depression Rating Scale, score 0-60, where a high score indicates symtoms of depression. | at Baseline, 4 weeks, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial magnetic stimulation