Potwierdzająca skuteczność i bezpieczeństwo próby terapii napadów magnetycznych w depresji (CREST-MST)

Leczenie MST zostanie przeprowadzone przy użyciu MagPro MST z Cool TwinCoil nad korą czołową w pozycji środkowej przy użyciu stymulacji 100 Hz. Określenie progu drgawkowego metodą MST zostanie przeprowadzone przy użyciu 100% mocy wyjściowej maszyny przyłożonej z częstotliwością 100 Hz przy stopniowo rosnącym czasie trwania pociągu, zaczynając od 2 sekund i zwiększając się o 2 sekundy z każdą kolejną stymulacją, aż do uzyskania odpowiedniego napadu. Podczas kolejnych sesji jedna stymulacja zostanie dostarczona z wykorzystaniem czasu trwania pociągu, który jest o 4 sekundy dłuższy niż czas trwania pociągu na progu (przy maksymalnym czasie trwania pociągu wynoszącym 10 sekund).

Odbędzie się to pod wpływem znieczulenia. Zabieg trwa około 10 minut, po czym następuje okres rekonwalescencji około 30 minut.

• MST

• EW

This scale is used to quantify the severity of symptoms of depression

• Scale range: 0-76 (total score)
• Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
• Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Remission defined as a HRSD-24 total score of ≤10 and 60% reduction from baseline on two consecutive assessments.

The outcome is reported as number of participants meeting remission criteria in each treatment group.

In the Autobiographical Memory Test (AMT), participants are presented with emotional cue words and asked to retrieve a personal memory within a brief response window; interview formats have been shown to produce fewer specific and more overgeneral memories.

The outcome is reported as the number of participants who meet the predefined worsening criterion at follow-up.

The binary outcome was defined as a worsening from baseline of >25% on the AMT total score.

Remission of suicidal ideation will be assessed using the Scale for Suicidal Ideation (SSI), a clinician-administered tool with 19 scored items rated 0-2, total score range 0-38. Higher scores indicate greater suicidal ideation severity.

Remission is defined as an SSI total score of 0 at follow-up. The outcome is the number of participants who meet remission criteria compared with baseline.

This scale is used to quantify the severity of symptoms of depression

• Scale range: 0-76 (total score)
• Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
• Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Response is defined as a HRSD-24 reduction of 50% or greater from baseline The outcome is reported as number of participants meeting response criteria in each treatment group.

The Brief Symptom Inventory (BSI) anxiety section (ANX) is a subscale comprised of 6 items designed to measure subjective experiences of tension, panic, and restlessness over the past week. It uses a 5-point Likert scale (0=not at all to 4=extremely) to identify symptoms like "nervousness," "feeling tense," or "spells of terror".

Higher = worse; lower = better. The total score ranges from 0 to 24.

The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point, observer-rated tool used to measure how much a patient's illness has improved or worsened relative to their baseline. It is rated from 1 (very much improved) to 7 (very much worse).

Response is defined as a CGI-I score of 1 or 2.

The Columbia ECT Subjective Side Effects Schedule is a tool used to monitor adverse effects after each ECT session and at baseline. It tracks physical, cognitive, and mood side effects.

For the physical scale (range 0-15) and cognitive scale (range 0-6) it uses a 4-point Likert-type scale where 0 = none; 1 = yes, mild; 2 = yes, moderate; and 3 = yes, severe.

For the mood scale (range 0-3) it uses a 2-point Likert-type scale where 0 = no; 1 = yes.

For the physical and cognitive scales, higher values indicate a worse outcome. For the mood scale, higher values indicate a better outcome.