Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02863094 |
Other study ID # |
NSFC-81171273-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2016 |
Est. completion date |
August 2021 |
Study information
Verified date |
October 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 continuous transcranial magnetic stimulation on
schizophrenia patients with auditory hallucinations, and the underlying neural mechanism by
functional MRI
Description:
All patients underwent a medical evaluation that included physical examination and routine
laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS)
treatment. Patients were randomly allocated to rTMS group and the sham group by random
number. 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 rTMS
administrators had access to the randomization list; they had minimal contact with the
patients, and no role in assessing AVH and other measures. Each patient would be treated for
continuous 15 days by rTMS
Before the rTMS treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating
Scale, and the Positive and Negative Syndrome Scale were obtained by a trained investigator
to assess baseline severity of auditory verbal hallucination (AVH) and other symptoms. 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.
After the last treatment, the Auditory Hallucination Rating Scale, Psychotic Symptom Rating
Scale, and 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 15 days. The patients had also receiving a battery measure of
neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
A month after the last treatment, participants were interviewed to obtain the Auditory
Hallucination Rating Scale, Psychotic Symptom Rating Scale, the Positive, and Negative
Syndrome Scale. 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.