RTMS Feasibility Study on Adolescent Depression Stimulation

NCT ID: NCT06126198

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

Brief Summary

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

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.

Conditions

Major Depressive Disorder; Unipolar Depression; Bipolar Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active treatment

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

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uppsala University

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

Teen-TMS_UU2023

Identifier Type: -

Identifier Source: org_study_id