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

NCT ID: NCT05543421

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rTMS active

Group Type: ACTIVE_COMPARATOR

TMS

Intervention Type: DEVICE

rTMS (30sessions) or iTBS (40sessions)

rTMS sham

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: DEVICE

rTMS (30sessions) or iTBS (40sessions)

iTBS active

Group Type: EXPERIMENTAL

TMS

Intervention Type: DEVICE

rTMS (30sessions) or iTBS (40sessions)

iTBS sham

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: DEVICE

rTMS (30sessions) or iTBS (40sessions)

Interventions

TMS

rTMS (30sessions) or iTBS (40sessions)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wroclaw Medical Univeristy, Department of Psychiatry

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Joanna Rymaszewska, Professor

Role: primary

psychiatria@umw.edu.pl

71 784 16 00

Other Identifiers

SUBZ.C230.22.062.TMS.MDD

Identifier Type: -

Identifier Source: org_study_id