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Transcranial Direct/ Alternating Current Stimulation for Parkinson's Disease Treatment

Primary Purpose

Parkinson Disease, tACS, tDCS

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tACS
tDCS
sham
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Transcranial Alternating Current Stimulation

Transcranial Direct Current Stimulation

Sham Group with No Actual Stimulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
the changes in MoCA
Montreal Cognitive Assessment is a 30-question test to assess cognitive function. Lower scores mean a worse cognitive status.

Secondary Outcome Measures

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.
the changes in EEG power
EEG recording by 8 channels EEG device. The EEG power in alpha, beta, delta, and theta bands will be investigated

Full Information

First Posted
December 14, 2022
Last Updated
January 9, 2023
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05678725
Brief Title
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 and Cognitive Performance in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 slide effects) to assess adverse events of the treatment. The patients also received a measure of electroencephalography (EEG) recorded during the resting state and a simple reaction task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, tACS, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Alternating Current Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Transcranial Direct Current Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Group with No Actual Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tACS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham
Intervention Description
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 0mA for 20 minutes with the ramp up and down time of 40 seconds.
Primary Outcome Measure Information:
Title
the changes in UPDRS III
Description
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)
Title
the changes in MoCA
Description
Montreal Cognitive Assessment is a 30-question test to assess cognitive function. Lower scores mean a worse cognitive status.
Time Frame
pre-stimulation; post-stimulation (immediately after stimulation)
Secondary Outcome Measure Information:
Title
simple reaction task
Description
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)
Title
the changes in EEG power
Description
EEG recording by 8 channels EEG device. The EEG power in alpha, beta, delta, and theta bands will be investigated
Time Frame
pre-stimulation; post-stimulation (immediately after stimulation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junjie Bu, Professor
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China

12. IPD Sharing Statement

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Transcranial Direct/ Alternating Current Stimulation for Parkinson's Disease Treatment

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