iTBS on Negative Symptoms and Cognitive Function in Schizophrenia

NCT ID: NCT05137158

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-06-14

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

iTBS stimulation

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.

Group Type: EXPERIMENTAL

Intermittent theta burst stimulation

Intervention Type: DEVICE

Intermittent theta burst stimulation(iTBS) on the left DLPFC, the left DLPFC will be targeted utilizing the localite neuronavigation system. The stimulation intensity is set at 80% of resting motor threshold(RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds.

Sham stimulation

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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

The same procedure will be performed in sham group including the RMT assessment and the neuronavigation system for target localization, but the sham coil will vertical to the brain surface and deliver a very slight magnetic field, which have the same appearance and sound, and provide the same tactile sensations as the active coils.

Interventions

Intermittent theta burst stimulation

Intermittent theta burst stimulation(iTBS) on the left DLPFC, the left DLPFC will be targeted utilizing the localite neuronavigation system. The stimulation intensity is set at 80% of resting motor threshold(RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds.

Intervention Type: DEVICE

Sham stimulation

The same procedure will be performed in sham group including the RMT assessment and the neuronavigation system for target localization, but the sham coil will vertical to the brain surface and deliver a very slight magnetic field, which have the same appearance and sound, and provide the same tactile sensations as the active coils.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renrong Wu, Prof

Role: PRINCIPAL_INVESTIGATOR

The Second Xiangya Hospital of Central South University Psychiatry Department

Locations

Second Xiangya Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

WU202110TBS

Identifier Type: -

Identifier Source: org_study_id