Using nTMS to treat negative symptoms in schizophrenia
Effectiveness of Navigated Transcranial Magnetic Stimulation (nTMS) of Left Supramarginal Gyrus for Negative Symptoms : A Double-blind, Randomized Controlled Trial
This study is testing if a new brain stimulation treatment can help reduce negative symptoms in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 60 Years |
| Sex | All |
| Sponsor | Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06642675 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of Navigated transcranial magnetic stimulation (nTMS) targeting the left Supramarginal Gyrus for alleviating negative symptoms in patients with schizophrenia. In a double-blind, randomized controlled design, participants will be assigned to either an active intermittent theta burst stimulation (iTBS) group or a sham stimulation group. The treatment will be administered five times a day over a period of 10 days, with assessments conducted at baseline, immediately after treatment, and one month post-treatment to measure outcomes such as symptom severity. The study will also collect demographic and clinical data to better understand the patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals under 60 years old with a clinical diagnosis of schizophrenia and significant negative symptoms.
Not a fit: Patients with neurodevelopmental disorders, bipolar disorder, or severe physical illnesses may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of negative symptoms in schizophrenia, enhancing patients' quality of life.
How similar studies have performed: While the use of TMS for various conditions has shown promise, this specific application for negative symptoms in schizophrenia is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion 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. 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 this trial is running
Changsha, Hunan
- Mental Health Institute of Second Xiangya Hospital,CSU — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Renrong Wu, M.D., Ph.D.
- Email: wurenrong2013@163.com
- Phone: 15874179855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.