Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03868358 |
Other study ID # |
ahmu-sjnk-scz |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 21, 2017 |
Est. completion date |
March 30, 2021 |
Study information
Verified date |
April 2021 |
Source |
Anhui Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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
Description:
All patients underwent a medical evaluation that included physical examination and routine
laboratory studies before and after intermittent theta-burst transcranial magnetic
stimulation (iTBS) treatment. Patients were randomly allocated to iTBS group and the sham
group by coin toss. There are about 30 patients in each group.The decision to enroll a
patient was always made prior to randomization. Patients were studied using a double-blind
design. Study participants, clinical raters, and all personnel responsible for the clinical
care of the patient remained masked to allocated condition and allocation parameters. Only
iTBS administrators had access to the randomization list; they had minimal contact with the
patients, and no role in assessing the Positive and Negative Syndrome Scale (PANSS). Each
patient would be treated for continuous 14 days by iTBS.Before the iTBS treatment, PANSS and
Clinical Global Impression-severity of illness (CGI-SI) at baseline were obtained by a
trained investigator to assess baseline severity of their symptoms. Scale for the Assessment
of Negative Symptoms (SANS) and Scale for Assessment of Positive Symptoms (SAPS) were
respectively supplemented to evaluate the severity of symptoms in different dimensions,.The
patients had receiving a battery measure of neuropsychological tests (standardized tests to
investigate their cognitive problems, anxiety and depressive symptoms in daily life),
magnetic resonance imaging scan in multimodalities, electroencephalography (EEG),
event-related potentials during stop signal test and Iowa-gambling test record. Other
behavioral tests including intertemporal decision,spatial n-back test record.
After the last treatment, the Positive and Negative Syndrome Scale were obtained, as well as
the Global Index of Safety to assess adverse events of the treatment. Patients were
instructed to focus their answers on the past 14 days. The patients had also receiving a
battery measure of neuropsychological tests, magnetic resonance imaging scan in
multimodalities, and EEG record.Clinical Global Impression-global improvement (CGI-GI),
Clinical Global Impression-efficacy index (CGI-EI) were evaluated at the end of treatment.
40-60 days after the last treatment, participants were interviewed to obtain the Positive and
Negative Syndrome Scale,SAPS,SANS and HAMA,HAMD. They were instructed to focus their answers
on the past week. Additionally, they were also asked to assess the battery of
neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and
EEG record. Afterwards, they were unblinded by the study coordinator.