Clinical trial NCT06126198: RTMS Feasibility Study on Adolescent Depression Stimulation
Official title: 1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Unipolar Depression
Bipolar Depression
Keywords: repetitive transcranial magnetic stimulation
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2023-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inclusion rate -
timeFrame: two years
measure: Attrition rate
timeFrame: two years
Secondary outcomes:
measure: CGAS (Children's Global Assessment Scale) score
timeFrame: 4 weeks, 6 weeks
measure: MADRS (Montgomery and Asberg Depression Rating Scale) score
timeFrame: at Baseline, 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
References: