A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Drug: Antipsychotic drugsDevice: cTBS （the left cerebellum Crus II as the stimulation target）Device: cTBS（the left temporoparietal cortex as the stimulation target）
- Registration Number
- NCT05039489
- Lead Sponsor
- Central South University
- Brief Summary
This study is dedicated to exploring the brain mechanism of medication-resistant auditory hallucinations and developing effective treatment methods for them by using both cross-sectional and longitudinal designs. The continuous theta burst stimulation(cTBS) treatment mode, with the left cerebellum Crus II as the stimulation target, is applied to treat the schizophrenia patients with the medication-resistant auditory hallucinations. At the same time, the first-episode schizophrenia patients with auditory hallucinations were recruited as a test cohort to examine that brain mechanism of general auditory hallucinations in schizophrenia may be the structural and functional abnormalities in the temporoparietal circuit.
- Detailed Description
Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) targeted at the temporal-parietal junction can effectively treat genenal auditory hallucinations in schizophrenia, but it is not the case for medication-resistant auditory hallucinations. Studies suggested that rTMS targeted at the left Crus II might be effective for medication-resistant auditory hallucinations. This study is dedicated to exploring the brain mechanism of medication-resistant auditory hallucinations and developing effective treatment methods for them by using both cross-sectional and longitudinal designs. The continuous theta burst stimulation(cTBS) treatment mode, with the left cerebellum Crus II as the stimulation target, is applied to treat the schizophrenia patients with the medication-resistant auditory hallucinations. Assessment with symptomatology, neuropsychology, neuroimaging, and machine learning methods is utilized to examine the investigators hypothesis that structural and functional abnormalities of the cerebral cortico-cerebellar-thalamic-cortical circuit (CCTCC) may contribute to brain mechanism of medication-resistant auditory hallucinations in schizophrenia. At the same time, the first-episode schizophrenia patients with auditory hallucinations were recruited as a test cohort to examine that brain mechanism of general auditory hallucinations in schizophrenia may be the structural and functional abnormalities in the temporoparietal circuit, whereas structural and functional abnormalities of the CCTCC may contribute to brain mechanism of medication-resistant auditory hallucinations in schizophrenia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Written informed consent
- 18-45 years old, right-handed
- Meet the diagnostic criteria for schizophrenia according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- After a sufficient course of antipsychotic treatment (more than 6 weeks, two or more antipsychotic drugs, at least one of which is the second generation of atypical antipsychotic drugs), auditory hallucinations occurred more than 5 times a day for more than 6 months
- Stable antipsychotic medication 4 weeks before and during the treatment (except auditory hallucination symptoms)
- A history of epilepsy, convulsions, stroke or other serious brain diseases
- There are serious infectious diseases, malignant tumors, and severe somatic comorbidity
- Mental retardation, personality disorder and so on
- Contraindications for magnetic resonance imaging
- Diagnose of substance dependence or abuse as primary clinical problem
- Pregnancy
- Participants had received Modified Electraconvulsive Therapy (MECT) or TMS treatment in recent 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description The schizophrenia patients with medication-resistant auditory hallucinations Antipsychotic drugs Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target) The schizophrenia patients with medication-resistant auditory hallucinations cTBS （the left cerebellum Crus II as the stimulation target） Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target) The schizophrenia patients with general auditory hallucinations Antipsychotic drugs Drug intervention Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations Antipsychotic drugs Drug + cTBS intervention (the left temporoparietal cortex as the stimulation target) Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations cTBS（the left temporoparietal cortex as the stimulation target） Drug + cTBS intervention (the left temporoparietal cortex as the stimulation target) Drug intervention: the first-episode schizophrenia patients with auditory hallucinations Antipsychotic drugs Drug intervention The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm Antipsychotic drugs Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target) The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm cTBS （the left cerebellum Crus II as the stimulation target） Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)
- Primary Outcome Measures
Name Time Method Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH) From baseline to 10 weeks The Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH) is an instrument designed to quantify the severity of hallucinations before and after treatment at different follow up point. Raw score range is 0-44. A higher score indicates a worse outcome.
Structural and Function MRI data From baseline to 10 weeks A 3.0 T Siemens scanner was used to obtain the fMRI images in the Second Xiangya Hospital of Central South University.The MRI data wii be obtained before and after treatment at different follow up point.
Positive and Negative Syndrome Scale (PANSS) From baseline to 10 weeks The PANSS total scores, subscale scores were used to evaluate the severity of psychotic symptoms for schizophrenia before and after treatment at different follow up point.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) From baseline to 10 weeks Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Stroop test From baseline to 10 weeks Pre-post assessment of cognitive function via the Stroop test
Wisconsin Card Sorting Test (WCST) From baseline to 10 weeks Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST)
Trial Locations
- Locations (1)
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, China
The Second Xiangya Hospital of Central South University🇨🇳Changsha, China