Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Transcranial direct current stimulation
Brief summary
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
Detailed description
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize first night effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
Interventions
PROCEDUREActive tDCS
Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
PROCEDURESham tDCS
Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
Sponsors
Rush University Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
Great Lakes NeuroTechnologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD brain bank criteria * Hoehn and Yahr stage II-III when off anti-parkinsonian medication * Able to provide informed consent * Currently taking levodopa (300-800 mg per day) * On stable regimen of anti-parkinsonian medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study * Presence of early morning akinesia * Naïve to tDCS.
Exclusion criteria
* Children will be excluded from this study due to the fact that they are unlikely to have PD * Significant medical or psychiatric illness, significant neurological disease other than PD, metal objects and/or deep brain stimulators in the head that might pose a hazard during tDCS * Dementia, as evidenced by a score less than 26 on the Montreal Cognitive Assessment * Significant depression (Geriatric Depression Scale score \< 20) * Presence of hallucinations * Having undergone any surgical procedure for treatment of PD including deep brain stimulation (DBS), pallidotomy, thalamotomy, or other brain surgeries * A history of seizures * A known history of severe sleep apnea or sleep onset insomnia * Skin diseases that could potentially cause irritations under electrodes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD motor scores measured by Kinesia HomeView | Average change from two days before tDCS sleep study to two days after tDCS sleep study | PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Polysomnography | During each sleep study | Polysomnography parameters will be compared during the active and sham tDCS sleep studies. |
| Sleepiness | Average change from two days before tDCS sleep study to two days after tDCS sleep study | Epworth Sleepiness Scale |
| tDCS sensations | Day after tDCS sleep studies | Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study. |
| Motor scores measured by the Unified Parkinson's Disease Rating Scale | Average change from day before tDCS sleep study to day after tDCS sleep study | — |
Countries
United States
Outcome results
None listed