Bipolar Depression, Major Depressive Disorder, Unipolar Depression
Conditions
Keywords
repetitive transcranial magnetic stimulation
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.
Interventions
DEVICERepetitive 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
Sponsors
Uppsala University Hospital
Uppsala University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inclusion rate - | two years | Participant inclusion during the course of the study |
| Attrition rate | two years | Participant drop-off during the course of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGAS (Children's Global Assessment Scale) score | 4 weeks, 6 weeks | Children's Global Assessment Scale, score 1-100, where a high score indicates high functioning. |
| MADRS (Montgomery and Asberg Depression Rating Scale) score | at Baseline, 4 weeks, 6 weeks | Montgomery and Asberg Depression Rating Scale, score 0-60, where a high score indicates symtoms of depression. |
Countries
Sweden
Outcome results
None listed