NCT06566313

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2024-04-30
• First posted: 2024-08-22
• Last updated: 2024-12-18

Locations

1 site across 1 country: China