Clinical trial NCT02125383: ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
Official title: ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Transcranial direct current stimulation
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-04-29
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PD motor scores measured by Kinesia HomeView
timeFrame: Average change from two days before tDCS sleep study to two days after tDCS sleep study
Secondary outcomes:
measure: Sleepiness
timeFrame: Average change from two days before tDCS sleep study to two days after tDCS sleep study
measure: tDCS sensations
timeFrame: Day after tDCS sleep studies
measure: Motor scores measured by the Unified Parkinson's Disease Rating Scale
timeFrame: Average change from day before tDCS sleep study to day after tDCS sleep study
measure: Overnight Polysomnography
timeFrame: During each sleep study
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Great Lakes NeuroTechnologies
name: Dustin A Heldman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: