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Completed

NCT Number: NCT06126198

RTMS Feasibility Study on Adolescent Depression Stimulation

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.

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Key information

Conditions

Major Depressive Disorder Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Unipolar Depression

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University

Uppsala, 75236, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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

Primary outcomes

  1. Inclusion rate -

    Time frame: two years

    Participant inclusion during the course of the study

  2. Attrition rate

    Time frame: two years

    Participant drop-off during the course of the study

Secondary outcomes

  1. CGAS (Children's Global Assessment Scale) score

    Time frame: 4 weeks, 6 weeks

    Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning.

  2. MADRS (Montgomery and Asberg Depression Rating Scale) score

    Time frame: at Baseline, 4 weeks, 6 weeks

    Montgomery and Asberg Depression Rating Scale, score 0-60, where a high score indicates symtoms of depression.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Official study title

1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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