A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia

NCT05039489 | Completed

• 1 other identifier: 82171508
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Medication-Resistant Auditory Hallucinations; Continuous theta burst stimulation，cTBS; Neuroimaging

Outcome Measures

Primary Outcomes (3)

• Psychotic Symptom Rating Scales-Auditory Hallucination Subscale (PSYRATS-AH)

  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.

  From baseline to 10 weeks

• Structural and Function MRI data

  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.

  From baseline to 10 weeks

• Positive and Negative Syndrome Scale (PANSS)

  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.

  From baseline to 10 weeks

Secondary Outcomes (3)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  From baseline to 10 weeks

• The Stroop test

  From baseline to 10 weeks

• Wisconsin Card Sorting Test (WCST)

  From baseline to 10 weeks

Study Arms (6)

The schizophrenia patients with medication-resistant auditory hallucinations

EXPERIMENTAL

Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)

Drug: Antipsychotic drugs; Device: cTBS （the left cerebellum Crus II as the stimulation target）

The schizophrenia patients with general auditory hallucinations

ACTIVE COMPARATOR

Drug intervention

Drug: Antipsychotic drugs

The healthy controls

NO INTERVENTION

MRI scan at baseline and no drugs treatment

Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations

EXPERIMENTAL

Drug + cTBS intervention (the left temporoparietal cortex as the stimulation target)

Drug: Antipsychotic drugs; Device: cTBS（the left temporoparietal cortex as the stimulation target）

Drug intervention: the first-episode schizophrenia patients with auditory hallucinations

ACTIVE COMPARATOR

Drug intervention

Drug: Antipsychotic drugs

The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm

EXPERIMENTAL

Drug + cTBS intervention (the left cerebellum Crus II as the stimulation target)

Drug: Antipsychotic drugs; Device: cTBS （the left cerebellum Crus II as the stimulation target）

Interventions

Antipsychotic drugs DRUG

Stable antipsychotic medication 4 weeks before and during the treatment. Chlorpromazine (CPZ) equivalent dosages were calculated for second- and first-generation antipsychotic drugs

Also known as: MRI scan

Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations; Drug intervention: the first-episode schizophrenia patients with auditory hallucinations; The schizophrenia patients with general auditory hallucinations; The schizophrenia patients with medication-resistant auditory hallucinations; The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm

cTBS（the left temporoparietal cortex as the stimulation target） DEVICE

Participants received 3 daily sessions of cTBS treatment. One session of cTBS was 40 seconds in duration and consisted of 3-pulse bursts at 50 Hz repeated every 200 milliseconds (5 Hz) until a total of 600 pulses was reached. To achieve cumulative aftereffects, this protocol was repeated 3 times and (1800 pulses in total) separated by two 15 minute breaks

Also known as: MRI scan

Drug + cTBS intervention: the first-episode schizophrenia patients with auditory hallucinations

cTBS （the left cerebellum Crus II as the stimulation target） DEVICE

Participants received 3 daily sessions of cTBS treatment. One session of cTBS was 40 seconds in duration and consisted of 3-pulse bursts at 50 Hz repeated every 200 milliseconds (5 Hz) until a total of 600 pulses was reached. To achieve cumulative aftereffects, this protocol was repeated 3 times and (1800 pulses in total) separated by two 15 minute breaks

Also known as: MRI scan

The schizophrenia patients with medication-resistant auditory hallucinations; The schizophrenia patients with medication-resistant auditory hallucinations from the fourth arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Antipsychotic Agents; Magnetic Resonance Spectroscopy; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wenbin Guo

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: September 9, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)