Parkinson Disease Clinical Trial
To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI
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 coin toss.
There are at least 20 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 clinical symptoms. Each patient would be treated for
continuous 14 days by rTMS.
Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor
Symptom Scale were obtained by a trained investigator to assess baseline severity. The
patients had receiving a battery measure of neuropsychological tests(mini-mental state
examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton
depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal
test, and delay discount), magnetic resonance imaging scan in multimodalities, and
electroencephalography (EEG) record.
In the second day after the last treatment, all the tests were reassessed. 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.
The clinical symptom and cognition of participants were followed in two month after the last
treatment. 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.
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