N/A
N=70
Study of Repetitive Transcranial Magnetic Stimulation in the Treatment of Cognitive Impairment in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01940939 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: The Change in the Severity of Negative Symptoms — 48.09; 50.33; 33.91; 41.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive Transcranial Magnetic Stimulation (Device)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Shanghai Mental Health Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in the Severity of Negative Symptoms |
48.09; 50.33; 33.91; 41.00; 68.15; 69.93 | — |
| SECONDARY MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version |
45.07; 43.58; 48.00; 49.04 | — |
Summary
1. Exploration of repetitive transcranial magnetic stimulation（rTMS）on working memory and cognitive impairment symptoms of schizophrenia treatment and mechanism.
2. Analysis of high-frequency repetitive transcranial magnetic stimulation stimulation to the improvement of negative symptoms and psychotic symptoms.
Eligibility Criteria
Inclusion Criteria
- 1）patients to be diagnosed according to the Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV) for paranoid schizophrenia；2）20～49 years old；3）Duration of 2 ~ 10 years;4）the disease situation is stable， the fluctuation of Positive and Negative Symptom Scale（PANSS）total score ≤10% in last 1 month, and have accepted the current drugs for more than 8 weeks; 5）Patients, their families and doctors are agreed that the disease situation is stable and maintained current drug treatment in next month；6）Signed an informed consent
Exclusion Criteria
- 1)patients to be diagnosed according to DSM-IV for substance abused,development delayed;2)suffering from serious physical disease and can not accept the treatment;3)repetitive transcranial magnetic stimulation(rTMS) contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure;4)the disease situation is not stable， the fluctuation of Positive and Negative Symptom Scale（PANSS）total score >10% in last 1 month, Positive and Negative Symptom Scale（PANSS）total score > 60;5)difficult to maintain the current drug treatment for at least 1 month;6）undergoing electroconvulsive therapy（ECT）in last 3 months.
Data sourced from ClinicalTrials.gov (NCT01940939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.