Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Not provided
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Positive and Negative Symptom Scale (PANSS) score
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1.Clinical diagnosis of schizophrenia according to ICD-
- •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.
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
Outcomes
Primary Outcomes
Change in Positive and Negative Symptom Scale (PANSS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The PANSS measures positive symptoms, negative symptoms and general psychopathology. It contains 30 items, each item is scored from 1 to 7, higher score indicates more severe psychopathology in the dimension. Here the investigators use the Chinese version of the PANSS to evaluate the severity of symptoms in schizophrenia in different participant and different treatment phase. The investigators mainly focus on change in the total score of the negative symptoms.
Change in Scale for Assessment of Negative Symptoms(SANS) score
Time Frame: Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)
The SANS measures the severity of negative symptoms in schizophrenia. It contains 24 items, each item is scored from 0 to 5, higher score indicates more severe symptom. The SANS evaluates five dimensions of the negative symptoms, which are apathy, poverty of thought, abulia, social withdrawal and disorders of attention.
Secondary Outcomes
- Change in Personal and Social Performance Scale (PSP) score(Baseline, 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(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(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(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change in MATRICS Consensus Cognitive Battery (MCCB) score(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(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))
- Change of electroencephalogram(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 in Calgary Depression Scale for Schizophrenia (CDSS) score(Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7))