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Completed

NCT Number: NCT05678725

Transcranial Direct/ Alternating Current Stimulation for Parkinson's Disease 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).

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Key information

Conditions

tACS tDCS

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Medical University

Hefei, Anhui, 230032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tACS

Device

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.

tDCS

Device

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.

SHAM

Device

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.

Primary outcomes

  1. the changes in UPDRS III

    Time frame: 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.

  2. the changes in EEG power

    Time frame: pre-stimulation; post-stimulation (immediate after stimulation)

    EEG recording by 8 channels EEG device.

Secondary outcomes

  1. simple reaction task

    Time frame: pre-stimulation; post-stimulation (immediately after stimulation)

    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.

  2. the changes in MoCA

    Time frame: pre-stimulation; post-stimulation (immediately after stimulation)

    Montreal Cognitive Assessment is a 30-question test to assess cognitive function.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 10, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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