iTBS on Negative Symptoms and Cognitive Function in Schizophrenia

Central South University

Status: Completed

Conditions: Schizophrenia

Treatments: Device: Sham stimulation; Device: Intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05137158

WU202110TBS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

66 participants in 2 patient groups

iTBS stimulation

Experimental group

Description:

The patients in iTBS stimulation group will receive iTBS stimulation on the target of the left dorsolateral prefrontal cortex for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention.

Treatment:

Device: Intermittent theta burst stimulation

Sham stimulation

Sham Comparator group

Description:

The participants in sham stimulation will receive sham stimulation, as the coil vertical to the brain surface, for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention.

Treatment:

Device: Sham stimulation