Clinical trial NCT05543421: Transcranial Magnetic Stimulation in Patients With a Depressive Episode - RCT Trial
Official title: Transcranial Magnetic Stimulation in Patients With a Depressive Episode
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: TMS
iTBS
MDD
RCT
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale
timeFrame: END of stimulation
measure: Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in MADRS scale
timeFrame: 3 months after end of stimulation
measure: Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in HAMD scale
timeFrame: END of stimulation
measure: Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in HAMD scale
timeFrame: 3 months after end of stimulation
measure: Comparison of efficiency of rTMS active and rTMS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale
timeFrame: END of stimulation
measure: Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS
timeFrame: 3 months after end of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical Univeristy, Department of Psychiatry
state: Dolnośląskie
Study officials:
References: