RTMS Feasibility Study on Adolescent Depression Stimulation

January 31, 2025 updated by: Uppsala University

1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Sweden
      • Uppsala, Sweden, 75236
        • Uppsala University

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:

  • 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

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: Active treatment
Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclusion rate -
Time Frame: two years
Participant inclusion during the course of the study
two years
Attrition rate
Time Frame: two years
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
Time Frame: 4 weeks, 6 weeks
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
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.
at Baseline, 4 weeks, 6 weeks

Collaborators and Investigators

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

Sponsor

Uppsala University

Collaborators

Uppsala University Hospital

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)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Teen-TMS_UU2023

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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