iTBS on Negative Symptoms and Cognitive Function in Schizophrenia
Study Details
Study Description
Brief Summary
The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia.Therefore, this study is designed to explore the potential benefits of rTMS, using iTBS pattern, on negative symptoms and cognitive deficits in schizophrenia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The negative symptoms and cognitive deficits are two core symptoms in patients with schizophrenia, and do not respond well to antipsychotics. There are many researches on the biological mechanism of these two symptoms, and some studies indicated that these two symptoms maybe related to the dysfunction of prefrontal cortex and deficiency of dopamine. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia.Therefore, this study is designed to explore the efficacy of rTMS, using iTBS pattern, on negative symptoms and cognitive deficits in schizophrenia.
This study is a randomized double-blind sham-controlled clinical trial. Patients with schizophrenia will be randomly treated with iTBS or sham condition to the bilateral dorsolateral prefrontal cortex for continuous 10 days, and the follow-ups are set at baseline and the 11th day. The main outcome measures include the change in MCCB score, PANSS score and EEG data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iTBS stimulation The patients in iTBS stimulation group will receive iTBS stimulation on the target of the bilateral dorsolateral prefrontal cortex for 10 consecutive days and 4 times per day.There will have at least 30 minutes interval between each intervention. |
Device: Intermittent theta burst stimulation
Intermittent theta burst stimulation(iTBS) on the bilateral DLPFC, the parameters of The parameters of iTBS are 90%RMT stimulation intensity, triplet 50Hz bursts, and repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds.
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| Sham Comparator: Sham stimulation The participants in sham stimulation will receive sham stimulation, as the coil vertical to the brain surface, for 10 consecutive days and 4 times per day.There will have at least 30 minutes interval between each intervention. |
Device: Sham stimulation
The coil will vertical to the brain surface, with the same parameters as iTBS.
|
Outcome Measures
Primary Outcome Measures
- Change in MCCB [Change from baseline to 10days]
The MATRICS Consensus Cognitive Battery,It can be used for cognitive assessment of schizophrenia, bipolar disorder and other neuropsychiatric diseases,The MCCB covers seven cognitive domains including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, and social cognition. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.
- Change in Positive and Negative Symptm Scale(PANSS) score [Change from baseline to 10days]
The scale to assess the severity of symptoms in schizophrenia.It is an evaluation scale of 30 disparate items scored from 1 to 7 for psychopathological symptoms observed in patients presenting psychotic syndromes, especially schizophrenic states.Three scores obtained with this scale are generally calculated for evaluating three dimensions of the syndrome: positive, negative and general psychopathology, as part of a categorial or dimensional perspective.The minimum value is 30 points, and the maximum value is 210 points.The higher the score, the more severe the relevant symptom is.
Secondary Outcome Measures
- The change in resting-state electro encephalograph [Change from baseline to 10days]
The recording of the electroencephalogram when the participants' eyes were opened ,closed and exposed to natural stimuli
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with schizophrenia in accordance with DSM-5
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The course lasts at least 2 years
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Received a steady dose of antipsychotic medication for least 3 months
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Show significant negative symptoms and cognitive impairment
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No obvious extrapyramidal side effects caused by antipsychotic drugs
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Informed Consent
Exclusion Criteria:
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Diagnosed with other mental disease in accordance with DSM-5
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Combined with other severe physiological disease
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Used antidepressants, mood stabilizer, or other psychoactive substances before
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Drug or alcohol abuse
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Pregnant or lactating
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Contraindication to rTMS
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Received rTMS or electroconvulsive therapy in the past 1 month
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Xiangya Hospital | Changsha | Hunan | China | 410000 |
Sponsors and Collaborators
- Central South University
Investigators
- Principal Investigator: Renrong Wu, Prof, The Second Xiangya Hospital of Central South University Psychiatry Department
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WU202110TBS