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临床试验/NCT05678725
NCT05678725已完成不适用

Comparison of Transcranial Direct Current Stimulation and Transcranial Alternating Current Stimulation Treatments in Improving the Motor Performance in Parkinson's Disease

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
the changes in UPDRS III

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Transcranial Alternating Current Stimulation

Active Comparator

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.

干预措施: tACS (Device)

Transcranial Direct Current Stimulation

Active Comparator

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.

干预措施: tDCS (Device)

Sham Group with No Actual Stimulation

Sham Comparator

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.

干预措施: sham (Device)

结局指标

主要结局

the changes in UPDRS III

时间窗: pre-stimulation; post-stimulation (immediate after stimulation)

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.

the changes in EEG power

时间窗: pre-stimulation; post-stimulation (immediate after stimulation)

EEG recording by 8 channels EEG device.

次要结局

  • simple reaction task(pre-stimulation; post-stimulation (immediately after stimulation))
  • the changes in MoCA(pre-stimulation; post-stimulation (immediately after stimulation))

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junjie Bu

Associate Professor

Anhui Medical University

研究点 (1)

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