Clinical trial NCT06642675: nTMS for Negative Symptom in Schizophrenia
Official title: Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
TMS
negative symptom
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 32
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 32 participants will be randomly divided into intervention group or sham group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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, course of disease less than 10 years.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Positive and Negative Symptom Scale (PANSS) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change in Scale for Assessment of Negative Symptoms(SANS) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Secondary outcomes:
measure: Change in MATRICS Consensus Cognitive Battery (MCCB) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: The data of head resting-state functional magnetic resonance imaging
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change in Personal and Social Performance Scale (PSP) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change in Global Assessment Function (GAF) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change of electroencephalogram
timeFrame: Baseline, first day of treatment (day 1), the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change of TMS-EEG (Transcranial Magnetic Stimulation Electroencephal
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
measure: Change in Calgary Depression Scale for Schizophrenia (CDSS) score
timeFrame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute of Second Xiangya Hospital,CSU
state: Hunan
Study officials:
affiliation: Mental Health Institute of Second Xiangya Hospital,CSU
name: Renrong Wu, M.D., Ph.D.
role: STUDY_CHAIR
References: