Transcranial Magnetic Stimulation in Patients With a Depressive Episode - RCT Trial

Major Depressive Disorder Clinical Trial

Official title: Transcranial Magnetic Stimulation in Patients With a Depressive Episode

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT05543421
• Study type: Interventional
• Source: Wroclaw Medical University
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: December 30, 2024