Anhui Medical University
Hefei, Anhui, 230032, China
NCT Number: NCT02969941
To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Hefei, Anhui, 230032, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The stimulations were performed by MagStim Rapid2.
Time frame: changes from baseline at 2 weeks post-treatment
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
Time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.
Time frame: changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms.
Time frame: changes from baseline at 1, 4, 6, and 10 weeks post-treatment
This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.
Anhui Medical University
Other
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