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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS group | Experimental | a course of tDCS treatment is performed for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| REM sleep behavior disorder questionnaire-Hong Kong | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panpan Hu, MD | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Neuropsychology Lab Anhui Medical University | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| baseline; day 10 |
| Pittsburgh sleep quality index | 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. | baseline; day 10 |
| EPworth Sleepiness Scale | 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. | baseline; day 10 |
| Parkinson disease sleep scale | 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. | baseline; day 10 |
| Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale | 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. | baseline; day 10 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |