nTMS for Negative Symptom in Schizophrenia
Recruiting · NCT06642675 · Interventional (participants receive a specific treatment) · Lead sponsor: Central South University
View the official record on ClinicalTrials.gov →Interventions studied
Intermittent theta burst stimulation(iTBS)Sham stimulation
What this trial is about
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.
Who can take part
Age range
Up to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
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
Where it is running
1 location listed.
- Mental Health Institute of Second Xiangya Hospital,CSU - Changsha, Hunan, China