transcranial magnetic stimulation in patients with a depressive episode - rct trial

Conditions: Major Depressive Disorder

Summary: the study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. a total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones with active rtms or itbs and 2 controls with sham-placebo rtms or itbs stimaltions).

the study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. a total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones and 2 controls): 1. eg1 (n=20) rtms stimulation (1 session daily per 30 days, 3000 pulses per session, session time = 37,5 minutes, 10hz), 2. eg2 (n=20) itbs stimulation (4 short sessions daily per 14 days, 600 pulses per session, session time=3 minutes, 50hz), 3. cg1 (n=10) placebo (sham-coil) stimulation based on rtms protocol, 4. cg2 (n=10) placebo (sham-coil) stimulation based on itbs protocol. efficacy will be analyzed on the intention-to-treat population, defined as participants who completed the baseline and at least one evaluation after rtms intervention. the following are the inclusion and exclusion criteria for the recruitment process: the following stimulation protocols will be used to conduct research into the treatment of depressive disorders: 1. stimulation with rtms within the left hemisphere, in the dorsolateral prefrontal cortex, dlpfc (dorsolateral prefrontal cortex). in the field of stimulation, a protocol based on fda recommendations, so- called train stimulation (stimulation of a given frequency for a short period of time with longer breaks without stimulation) assuming the following stimulation parameters: * magnetic field intensity: 120% of the initial excitability threshold for the motor cortex, * frequency: 10 hz for 4 seconds of stimulation, * breaks in stimulation: 26 seconds, * total number of stimulation pulses: 3000, * duration of one session: 37.5 minutes, * duration of therapy: from 4 to 6 weeks (sessions on days 1-5, break on days 6 and 7). 2. itbs protocol in the left cerebral hemisphere, in the dorsolateral prefrontal cortex, dlpfc (dorsolateral prefrontal cortex). expected range of parameters: * frequency: up to 50 hz, intensity: 80% excitability threshold for the motor cortex, * breaks between pulse series: up to 10 seconds * duration of a single session: from 20 to 190 seconds, * duration of treatment: 40 sessions, * total number of pulses in a session: 600, sessions a day: 4. * duration of one session: 3 minutes, * duration of therapy: 2 weeks (sessions on days 1-5, break on days 6 and 7).

Eligibility criteria:
inclusion criteria: * psychiatric diagnosis (f3x); * symptom severity - total score of the hamilton depression scale a least 17 * granting informed consent * the possibility for the patient to ensure constant participation in individual sessions and clinical evaluations, in particular in terms of place of residence and travel options * 18-70 years of age. exclusion criteria: * contraindications to treatments using tms * lack of informed consent from the patient * documented persistent lack of cooperation in treatment.

Keywords: tms itbs mdd rct