nTMS for Negative Symptom in Schizophrenia

Официальное название

Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial

Обзор

This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) of left Supramarginal Gyrus for negative symptoms. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. Treatment will last for 10 days, and data will be collected at baseline, 1 day and 1 month after treatment.

Подробное описание

This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) for negative symptoms in patients with schizophrenia. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. By using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus, and parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.Both group will receive nTMS 5 times a day, total treatment for 10 days. Measurements included a pretreatment measurement session, 10 days of nTMS treatment, a post-treatment measurement, and a follow-up measurement 1 month after treatment. At baseline, data of demographic variables (such as sex, age, years of education, occupational status, social support) and disease characteristics (such as duration of illness, antipsychotic daily dose in chlorpromazine equivalents, family psychiatric history) will be collected.At baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7) , data of outcomes (such as Positive and Negative Symptom Scale (PANSS) score,Negative Symptoms(SANS) score and other secondary outcomes) will be collected in order to test the effectiveness of nTMS. After completing the 1 month follow-up, patients may choose whether to continue follow-up , in order to observe the long-term effects of the treatment. However, they will not receive any further experimental interventions.

Вмешательства

• Устройство Intermittent theta burst stimulation(iTBS)
  By using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus.iTBS will be performed using Magstim Rapid² stimulator, parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.
• Устройство Sham stimulation
  Patients in sham group would receive the same intervention procedure as the active ITBS group, but the coil will be replaced with sham coil, which provides the sensation of TBS without enough magnetic energy to reach the cortex.

Первичные конечные точки

• Change in Positive and Negative Symptom Scale (PANSS) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change in Scale for Assessment of Negative Symptoms(SANS) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]

Вторичные конечные точки (8)

• Change in MATRICS Consensus Cognitive Battery (MCCB) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• The data of head resting-state functional magnetic resonance imaging [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change in Personal and Social Performance Scale (PSP) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change in Global Assessment Function (GAF) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change of electroencephalogram [Срок оценки: Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change of TMS-EEG (Transcranial Magnetic Stimulation Electroencephal [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change in Montgomery-Asberg Depression Rating Scale (MADRS) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]
• Change in Calgary Depression Scale for Schizophrenia (CDSS) score [Срок оценки: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)]

Критерии участия

Критерии включения

• 1.Clinical diagnosis of schizophrenia according to ICD-11.
• 2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).
• 3.Score more than 4 points on either item of negative symptoms (N1-N7).
• 4.Aged less than 60 years.

Критерии исключения

• 1.Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
• 2.Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, etc.
• 3.Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.
• 4.Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
• 5.Severe risk of self-injury or suicide
• 6.Other conditions where the researchers find unsuitable for the treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Mental Health Institute of Second Xiangya Hospital,CSU — Чанша

Идентификаторы

NCT: NCT06642675 · nTMS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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