RecruitingNot ApplicableNCT06642675

nTMS for Negative Symptom in Schizophrenia

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


Sponsor

Central South University

Enrollment

40 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 60 Years

Inclusion Criteria4

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

Exclusion Criteria6

  • Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
  • 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.
  • 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.
  • Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
  • Severe risk of self-injury or suicide
  • Other conditions where the researchers find unsuitable for the treatment

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Interventions

DEVICEIntermittent 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.

DEVICESham 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.


Locations(1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, China

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NCT06642675


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