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

Last updated: September 13, 2022
Sponsor: Wroclaw Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression (Major/severe)

Depression

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT05543421
SUBZ.C230.22.062.TMS.MDD
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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 individualsessions and clinical evaluations, in particular in terms of place of residence andtravel options
  • 18-70 years of age.

Exclusion

Exclusion Criteria:

  • Contraindications to treatments using TMS
  • Lack of informed consent from the patient
  • Documented persistent lack of cooperation in treatment.

Study Design

Total Participants: 60
Study Start date:
January 01, 2019
Estimated Completion Date:
December 30, 2024

Study 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).

Connect with a study center

  • Wroclaw Medical Univeristy, Department of Psychiatry

    Wrocław, Dolnośląskie 50-367
    Poland

    Active - Recruiting

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