NCT05678725

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

May 10, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

December 14, 2022

Last Update Submit

May 8, 2024

Conditions

tACStDCS

Outcome Measures

Primary Outcomes (2)

  • 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.

    pre-stimulation; post-stimulation (immediate after stimulation）

  • the changes in EEG power

    EEG recording by 8 channels EEG device.

    pre-stimulation; post-stimulation (immediate after stimulation)

Secondary Outcomes (2)

  • simple reaction task

    pre-stimulation; post-stimulation (immediately after stimulation)

  • the changes in MoCA

    pre-stimulation; post-stimulation (immediately after stimulation)

Study Arms (3)

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.

Device: tACS

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.

Device: tDCS

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.

Device: sham

Interventions

tACSDEVICE

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.

Transcranial Alternating Current Stimulation
tDCSDEVICE

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.

Transcranial Direct Current Stimulation
shamDEVICE

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.

Sham Group with No Actual Stimulation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

Related Publications (1)

  • Liu J, Zhu Y, Chen B, Meng Q, Hu P, Chen X, Bu J. Common and specific effects in brain oscillations and motor symptoms of tDCS and tACS in Parkinson's disease. Cell Rep Med. 2025 Apr 15;6(4):102044. doi: 10.1016/j.xcrm.2025.102044. Epub 2025 Mar 27.

    PMID: 40154492DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Junjie Bu, Professor

    Anhui Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 10, 2023

Study Start

February 15, 2023

Primary Completion

January 15, 2024

Study Completion

February 15, 2024

Last Updated

May 10, 2024

Record last verified: 2024-02

Locations

CN(1)