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

Not Applicable

Completed

• Conditions: Primary Left Motor Cortex; Transcranial Direct Current Stimulation; Parkinson Disease
• Interventions: Behavioral: transcranial Direct Current Stimulation

• Registration Number: NCT06566313
• Lead Sponsor: Anhui Medical University

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-04-30
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-15
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tDCS group	transcranial Direct Current Stimulation	a course of tDCS treatment is performed for 10 days

Primary Outcome Measures

Name	Time	Method
RBD Screening Questionnaire	baseline; day 10	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) .

Secondary Outcome Measures

Name	Time	Method
REM sleep behavior disorder questionnaire-Hong Kong	baseline; day 10	The RBDQ-HK questionnaire is a self-administered (by patient and/or bed partner) questionnaire comprising 13 questions per- taining to various clinical features of RBD as defined by the Inter- national Classification of Sleep Disorders (ICSD-II).The total RBD score was calcu- lated by the sum of the scores of all lifetime items and recent 1- year frequency items. The total RBD score has a range from 0 to 100.
Pittsburgh sleep quality index	baseline; day 10	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
EPworth Sleepiness Scale	baseline; day 10	The Epworth sleepiness scale (ESS) is asimple, self-administered questionnaire which is shown to provide a measurement of the subject's genera1level of daytime sleepiness.
Parkinson disease sleep scale	baseline; day 10	The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance.This is the description of a simple bedside screening instrument for evaluation of sleep disturbances in Parkinson's disease.
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale	baseline; day 10	The MDS-UPDRS is used to diagnose Parkinson's disease and assess the severity of symptoms, which is based on three major motor manifestations. Parkinson's disease is defined as bradykinesia with resting tremor, rigidity, or both.

Trial Locations

Locations (1)

Cognitive Neuropsychology Lab Anhui Medical University; 🇨🇳 Hefei, Anhui, China