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

tDCS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05678725
• Other study ID #: tAtDComparePD
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• tDCS

Intervention

Device:
• tACS
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
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
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.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	the changes in EEG power	EEG recording by 8 channels EEG device.	pre-stimulation; post-stimulation (immediate after stimulation)
Secondary	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.	pre-stimulation; post-stimulation (immediately after stimulation)
Secondary	the changes in MoCA	Montreal Cognitive Assessment is a 30-question test to assess cognitive function.	pre-stimulation; post-stimulation (immediately after stimulation)