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

NCT ID: NCT06566313

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-04-30

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.

Detailed Description

Rapid eye movement sleep behavior disorder (RBD) is one of the most common accompanying symptoms of Parkinson's disease (PD). PD-RBD patients have more severe clinical manifestations, require larger drug doses, and have more non-motor symptoms. Although several strategies using transcranial direct current stimulation (tDCS) have been investigated for the treatment of sleep disorders, the efficacy of high-definition tDCS (HD-tDCS) in PD-RBD patients remains unclear.

We conducted an open-label study using the RBD-SQ to identify individuals with possible RBD (pRBD), and recruiting the patients at the First Affiliated Hospital of Anhui Medical University to receive cathodal HD-tDCS intervention. On the basis of conventional anti-PD drugs, cathodal HD-tDCS treatment was performed on the left M1 area once a day for 20 minutes, and the treatment was continued for 10 days. The International Movement Disorders Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the Hoehn & Yahr staging scale (H&Y), REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), RBD Screening Questionnaire Hong Kong (RBDSQ- HK), Pittsburgh sleep quality index (PSQI), Epworth Sleepiness Scale (ESS), and Parkinson disease sleep scale (PDSS) were assessed on intervention Day 1 and Day 10, and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Conditions

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

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS group

a course of tDCS treatment is performed for 10 days

Group Type: EXPERIMENTAL

transcranial Direct Current Stimulation

Intervention Type: 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.

Interventions

transcranial Direct Current Stimulation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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).

2. The total score of RBD Screening Questionnaire (RBDSQ) is ≥6 points.

3. 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.

4. Good compatibility, with a certain degree of compliance;

5. Normal mental condition, able to cooperate with behavioral tests and transcranial electrical stimulation treatment;

Exclusion Criteria

1. The patient has a metal object or skull brace device or any similar metal object on the scalp;

2. Head tremor or limb shaking is so severe that it is difficult to calmly receive treatment;

3. The presence of other serious mental illness (such as major depression, psychosis or obsessive-compulsive disorder, physical illness or a history of substance abuse);

4. Have a head injury, stroke or other neurological disorder;

5. The diagnosis of PD dementia is difficult to complete the assessment.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Panpan Hu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Locations

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

AHMU-tDCS-PD

Identifier Type: -

Identifier Source: org_study_id