NCT05039489Completed
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 31 Aug 2021
- Start date
- 9 Sept 2021
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- Central South University
- Diseases
- Schizophrenia
- NCT number
- NCT05039489
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 9 Sept 2021 to the primary completion date, 31 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants had received Modified Electraconvulsive Therapy (MECT) or TMS treatment in recent 6 months
Other illness
- 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
Other
- Contraindications for magnetic resonance imaging
- Diagnose of substance dependence or abuse as primary clinical problem
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.