Clinical trial NCT05678725: Transcranial Direct/ Alternating Current Stimulation for Parkinson's Disease Treatment
Official title: Comparison of Transcranial Direct Current Stimulation and Transcranial Alternating Current Stimulation Treatments in Improving the Motor Performance in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: tACS
tDCS
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic PD according to the movement disorder society criteria
* right-handed
* no clinically known hearing or vision impairment
* no history of epilepsy, dementia, other brain disorders apart from PD, severe internal organs disease, age-related frailty, etc.

Exclusion Criteria:

* parkinsonism due to drugs, Cerebrovascular disease, encephalitis, poisoning, traumatic brain injury, etc.
* Metal implants in the head (i.e., deep brain stimulator or aneurysm clips)
* severe somatic or psychiatric disorders that require medication or routinely monitoring
* participated in other interventional studies within the past 3 months

Primary outcomes:
measure: the changes in UPDRS III
timeFrame: pre-stimulation; post-stimulation (immediate after stimulation）
measure: the changes in EEG power
timeFrame: pre-stimulation; post-stimulation (immediate after stimulation)
Secondary outcomes:
measure: simple reaction task
timeFrame: pre-stimulation; post-stimulation (immediately after stimulation)
measure: the changes in MoCA
timeFrame: pre-stimulation; post-stimulation (immediately after stimulation)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Junjie Bu, Professor
role: STUDY_CHAIR
References: