Clinical trial NCT05137158: iTBS on Negative Symptoms and Cognitive Function in Schizophrenia
Official title: The Effect of Intermittent Theta Burst Stimulation on Negative Symptoms And Cognitive Function in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
iTBS
Negative Symptom
Cognitive function
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sixty participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.
Primary purpose: TREATMENT

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. In this study, we explore the effects of iTBS on negative symptoms and cognitive function based on identifying the brain network connection of schizophrenia symptoms.

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 explore the efficacy of iTBS on negative symptoms and cognitive deficits in schizophrenia based on identifying the brain network connection of schizophrenia symptoms.

Firstly, we have used neuroimaging to find the left prefrontal cortex that is responsible for negative symptoms and cognitive function in schizophrenia. Then,we design this randomized double-blind sham-controlled clinical trial. Patients with schizophrenia will be randomly treated with iTBS or sham condition to the left dorsolateral prefrontal cortex(L-DLPFC) for continuous 10 days, theL-DLPFC will be targeted utilizing the localite neuronavigation system. The follow-ups are set at baseline, the 11th day and the 30th day after the end of treatment. The main outcome measures include the change in MCCB score, PANSS score, SANS score, SAPS score and the resting-state functional magnetic resonance imaging data.

Eligibility criteria: Inclusion Criteria:

1. Patients with schizophrenia in accordance with DSM-5
2. The disease duration ≤8 years
3. Received a steady dose of antipsychotic medication for least 4 weeks
4. The Global Deficit Score of MCCB ≥0.5 or the PANSS negative subscore ≥20
5. No obvious extrapyramidal side effects caused by antipsychotic drugs
6. Informed Consent

Exclusion Criteria:

1. Diagnosed with other mental disease in accordance with DSM-5
2. Combined with other severe physiological disease
3. Used antidepressants, mood stabilizer, or other psychoactive substances before
4. Drug or alcohol abuse
5. Pregnant or lactating
6. Contraindication to rTMS
7. Received rTMS or electroconvulsive therapy in the past 1 month

Primary outcomes:
measure: Change in MCCB
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
measure: Change in Positive and Negative Symptm Scale(PANSS) score
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
measure: Change in Scale for Assessment of Positive Symptoms(SAPS) score
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
measure: Change in Scale for Assessment of Negative Symptoms(SANS) score
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
measure: The data of resting-state functional magnetic resonance imaging
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
Secondary outcomes:
measure: Change in Treatment Emergent Symptom Scale(TESS) score
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
measure: The blood sample
timeFrame: From baseline to 11days and the 30th day after the end of stimulation
Other outcomes:
Locations:
city: Changsha
country: China
facility: Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: The Second Xiangya Hospital of Central South University Psychiatry Department
name: Renrong Wu, Prof
role: PRINCIPAL_INVESTIGATOR
References: