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

Wroclaw Medical University

Status: Enrolling

Conditions: Major Depressive Disorder

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT05543421

SUBZ.C230.22.062.TMS.MDD

Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

60 participants in 4 patient groups

rTMS active

Active Comparator group

Treatment:

Device: TMS

rTMS sham

Sham Comparator group

Treatment:

Device: TMS

iTBS active

Experimental group

Treatment:

Device: TMS

iTBS sham

Sham Comparator group

Treatment:

Device: TMS