An Open-label Study on the Clinical Efficacy of tDCS Intervention in PD

NCT06566313 | Completed

• 1 other identifier: AHMU-tDCS-PD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that intervention targeting the primary motor area (M1) using transcranial Direct Current Stimulation can improve sleep symptoms in patients with Parkinson's disease.

Conditions

Transcranial Direct Current Stimulation; Parkinson Disease; Primary Left Motor Cortex

Keywords

Transcranial Direct Current Stimulation; Parkinson Disease; primary left motor cortex

Outcome Measures

Primary Outcomes (1)

• RBD Screening Questionnaire

  The RBD Screening Questionnaire (RBDSQ) is the most widely used tool over the past decade and includes 13 yes-or-no questions regarding the presence of move- ments and dream-enacting behaviours during sleep(maximum total score 13 points) .

  baseline; day 10

Secondary Outcomes (5)

• REM sleep behavior disorder questionnaire-Hong Kong

  baseline; day 10

• Pittsburgh sleep quality index

  baseline; day 10

• EPworth Sleepiness Scale

  baseline; day 10

• Parkinson disease sleep scale

  baseline; day 10

• Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale

  baseline; day 10

Study Arms (1)

tDCS group

EXPERIMENTAL

a course of tDCS treatment is performed for 10 days

Behavioral: transcranial Direct Current Stimulation

Interventions

transcranial Direct Current Stimulation BEHAVIORAL

On the basis of conventional anti-PD drugs, the left M1 region (based on the C3 coordinates of EEG 10-20 system and the surrounding FC1, FC5, CP1, CP5 coordinates) was treated with cathodic tDCS. The electrical stimulation intensity was 2.0mA, the treatment time was 20min, and the treatment lasted for 10 days.

tDCS group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of PD was determined by neurologists with rich clinical work experience, and was in line with the diagnostic criteria for Parkinson's disease in China (2016 edition).
• The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.
• All patients took the drug stably and had no history of drug adjustment within 2 months before treatment. The test was conducted 2 hours after taking the drug.
• Good compatibility, with a certain degree of compliance;
• Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;

You may not qualify if:

• The patient has a metal object or skull brace device or any similar metal object on the scalp;
• Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;
• The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);
• Have a head injury, stroke or other neurological disorder;
• The diagnosis of PD dementia is difficult to complete the assessment.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Panpan Hu, MD

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)