Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03736291 |
Other study ID # |
JunCai |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 2019 |
Est. completion date |
June 2021 |
Study information
Verified date |
September 2021 |
Source |
Shanghai Mental Health Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has
been shown to improve symptoms in patients with schizophrenia, but the underlying neural
mechanism is unknown.This study hypothesized that repetitive transcranial magnetic
stimulation of the cerebellar vermis can alter the ciliary-related functional connections in
schizophrenia, thereby improving negative symptoms, cognitive function, and emotional
symptoms. Therefore, this study will firstly explore the difference in cerebellar functional
connectivity between patients and healthy controls, and on this basis, patients undergo a
resting state functional magnetic resonance scan before and after rTMS intervention in the
cerebellar vermis, and observe the cerebellar function connection in the treatment. Before
and after changes, analyze the relationship between these changes and clinical efficacy to
explore the neural mechanisms of efficacy.
Description:
Repetitive Transcranial Magnetic Stimulation (rTMS) can modulate neuronal activity and has
been shown to improve symptoms in patients with schizophrenia, but the underlying neural
mechanism is unknown.This study hypothesized that repetitive transcranial magnetic
stimulation of the cerebellar vermis can alter the ciliary-related functional connections in
schizophrenia, thereby improving negative symptoms, cognitive function, and emotional
symptoms. Therefore, this study will firstly explore the difference in cerebellar functional
connectivity between patients and healthy controls, and on this basis, patients undergo a
resting state functional magnetic resonance scan before and after rTMS intervention in the
cerebellar vermis, and observe the cerebellar function connection in the treatment. Before
and after changes, analyze the relationship between these changes and clinical efficacy to
explore the neural mechanisms of efficacy.
1. Aim of the study 1.1 Using resting state functional magnetic resonance imaging to
observe the differences in cerebellar functional connections between schizophrenia
patients and healthy controls, and to further understand the role of cerebellar
abnormalities in the clinical symptoms of schizophrenia; 1.2 Provide evidence-based
evidence and imaging evidence for the clinical efficacy of rTMS intervention in
cerebellar palsy for patients with schizophrenia, and further understand the neural
mechanism of efficacy.
2. Content of the study 2.1 Based on previous studies, this study will use resting-state
functional magnetic resonance imaging to observe abnormalities in behavioral and
cerebellar neural networks in patients with schizophrenia compared with healthy
controls, and to explore these abnormalities and schizophrenia. The relationship between
clinical symptoms. 2.2 According to the research hypothesis, this study will perform a
resting-state functional magnetic resonance scan of the patient before and after rTMS
intervention in the cerebellar vermis. The functional connection analysis method is used
to observe the changes of the cerebellar nerve network before and after treatment, and
the imaging data and clinical evaluation. The data of the scale is combined to explore
the neural mechanisms of treatment.
3. Study design This study used resting-state functional magnetic resonance imaging to
investigate the differences in cerebrospinal function connections between schizophrenia
and healthy controls. Based on this, a randomized double-blind control design was used
to study the repetitive transcranial magnetic stimulation of the cerebellar vermis for
patients with schizophrenia. The clinical efficacy of the treatment and the neural
mechanisms of the therapeutic effect. Inpatients with schizophrenia were admitted to the
Shanghai Mental Health Center, and patients who met the criteria and successfully
enrolled were randomly grouped (by random number table method), corresponding to the
rTMS true stimulation group or the rTMS pseudo-stimulation group. Except for the rTMS
operator, neither the patient nor the evaluator of the scale knew the patient's
grouping.