RTMS Feasibility Study on Adolescent Depression Stimulation

Uppsala University

Status

Completed

Conditions

Major Depressive Disorder

Bipolar Depression

Unipolar Depression

Treatments

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06126198

Teen-TMS_UU2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

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