NCT05543421

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

Transcranial Magnetic Stimulation in Patients With a Depressive Episode

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wroclaw Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Detailed 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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	TMS	rTMS (30sessions) or iTBS (40sessions)

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2022-09-16
• Last updated: 2022-09-16

Locations

1 site across 1 country: Poland