An interventional study of tACS and tDCS in tACS and tDCS, sponsored by Anhui Medical University. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment
To investigate the difference in the treatment efficacy between transcranial direct current stimulation and transcranial alternating current stimulation on Parkinson's disease, including the improvements in the motor, cognitive, and underlying neural mechanisms behind differences in efficacy by electroencephalography (EEG).
All patients underwent a medical evaluation that include physical examinations and routine laboratory studies before and after stimulation sessions. Patients were randomly allocated to tACS, tDCS, and sham groups. There are about 20 patients in each group. Allocation was by computer generating random numbers. 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 conditions and allocation parameters. Only stimulation administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the UPDRS(Unified Parkinson´s Disease Rating Scale), Hoehn \& Yahr, and MoCA(Montreal Cognitive Assessment). Each patient would be treated for 20 minutes of transcranial electrical stimulation.
Before the stimulation session, UPDRS, Hoehn \& Yahr, and MoCA were obtained by a trained investigator to assess the baseline severity of symptoms. The patients received electroencephalography (EEG) recorded during resting state for 5 minutes.
During the stimulation session, patients were asked to perform simple reaction tasks at the same time.
After the stimulation session, UPDRS, Hoehn \& Yahr, and MoCA were obtained, as well as the Global Index of Safety（tES side effects） to assess adverse events of the treatment. The patients also received a measure of electroencephalography (EEG) recorded during the resting state.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Anhui Medical University is the lead sponsor of 102 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
the alternating current stimulation lasted 20 mins and was delivered at 2mA (peak to peak) at 20Hz during the Simple Reaction Task(SRT), targeting the primary motor cortex. EEG should be acquired before and after the stimulation session.
Device: tACS
the direct current stimulation lasted 20 minutes and was delivered at 2mA during the SRT, targeting at the primary motor cortex. EEG should be acquired before and after the stimulation session.
Device: tDCS
the procedure of this protocol lasted 20 minutes and was delivered at 0mA during the SRT. EEG should be acquired before and after the stimulation session.
Device: sham
used round electrodes（area:3.14cm2） and the montage of a bifrontal setup with C3 as the stimulation electrode, while the return electrode placed on the right shoulder . The dose was at 2mA, 20Hz for 20 minutes.
used round electrodes（area:3.14cm2） and the montage of a bifrontal setup with C3 as stimulation and C4 as return electrodes. The dose was at 2mA for 20 minutes.
used round electrodes（area:3.14cm2） and the montage of a bifrontal setup with C3 as stimulation and C4 as return electrodes. The stimulation lasted for 20 minutes and included a 10-second ramp-up and 10-second ramp-down.
the changes in UPDRS III
Unified Parkinson´s Disease Rating Scale Section III-motor is the sum of 18 items, each item contains 0-4 ratings, where 0=normal, 1= slight, 2= mild, 3=moderate, 4=severe.
Time frame: pre-stimulation; post-stimulation (immediate after stimulation）
the changes in EEG power
EEG recording by 8 channels EEG device.
Time frame: pre-stimulation; post-stimulation (immediate after stimulation)
simple reaction task
First , there was a fixation sign"+" appearing on the screen for 0.5 s, then, after 2-5 seconds, a black dot would appear. Participants were instructed to press the space bar as fast as possible when the black dot appears in the center of the screen, to measure simple perception and sustained alertness. The changes in accuracy(ACC), reaction time(RT), and ACC/RT were calculated.
Time frame: pre-stimulation; post-stimulation (immediately after stimulation)
the changes in MoCA
Montreal Cognitive Assessment is a 30-question test to assess cognitive function.
Time frame: pre-stimulation; post-stimulation (immediately after stimulation)
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Anhui Medical University