Schizophrenia Clinical Trial
Official title:
Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients
Verified date | April 2021 |
Source | Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the treatment effect of intermittent theta-burst transcranial magnetic stimulation on symptomatic relief of schizophrenia patients, and the underlying neural mechanism by functional MRI and the resting electroencephalogram
Status | Completed |
Enrollment | 60 |
Est. completion date | March 30, 2021 |
Est. primary completion date | July 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 52 Years |
Eligibility | Inclusion Criteria: - Patients met diagnostic criteria for schizophrenia or schizoaffective disorder using the Structural Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (SCID, Version 2.0). - Patients remain their psychotropic medication at steady dosages for at least 4 weeks prior to study entry and for the duration of the trial. - Verbal intelligence quotient > 85 as measured by using a Chinese version of the National Adult Reading Test. Exclusion Criteria: - History of significant head trauma or neurological disorders - Alcohol or drug abuse Focal brain lesions on T1- or T2-weighted fluid-attenuated inversion-recovery magnetic resonance images - a prior history of a seizure not induced by drug withdrawal,first degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease, such as thyroid disease, significant unstable medical condition, recent aggression or other forms of behavioral dyscontrol - left-handedness, pregnancy - estimated intelligence quotient<80 - current alcohol or drug abuse - inability to provide informed consent. - Hamilton Anxiety Rating Scale or the Hamilton Depression Rating Scale score > 14 |
Country | Name | City | State |
---|---|---|---|
China | Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
WANG KAI |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive And Negative Syndrome Scale(PANSS) | The improvment in PANSS scores will constitute the major research outcome measure used to assess response to rTMS,reflecting the symptom improvment in patients | Baseline and 2 weeks post-treatment,and follow-up | |
Secondary | Scale for the Assessment of Positive Symptoms (SAPS) | The improvment in SAPS scores will constitute the major research outcome, and specifically reflect the degree of improvement in patients' positive symptoms | Baseline and 2 weeks post-treatment and follow-up | |
Secondary | Scale for the Assessment of Negative Symptoms (SANS) | The improvment in SANS scores will constitute the major research outcome, and specifically reflect the degree of improvement in patients' negative symptoms | Baseline and 2 weeks post-treatment and follow-up | |
Secondary | Functional connectivity change of transcranial magnetic stimulation(iTBS and sham) | Functional MRI measures: the functional connectivity between stimulated target and the whole brain areas | Baseline and 2 weeks post-treatment | |
Secondary | EEG change of transcranial magnetic stimulation(iTBS and sham) | EEG measures: brain areas wave change of stimulation(iTBS and sham) | Baseline and 2 weeks post-treatment | |
Secondary | Intertemporal decision test | Intertemporal decision test is associated with the function of left dorsolateral prefrontal cortex | Baseline and 2 weeks post-treatment | |
Secondary | Spatial n-back test | Spatial n-back test will reflect the prefrontal function | Baseline and 2 weeks post-treatment | |
Secondary | Multidimensional Empathy Test | Multidimensional empathy Test is associated with the function of left dorsolateral prefrontal cortex | Baseline and 2 weeks post-treatment |
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