ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

Parkinson's Disease Clinical Trial

— ParkinStim  

Official title:

ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125383
• Other study ID #: 1R43NS077652-01A1
• Secondary ID: 1R43NS077652-01A
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: March 9, 2015
• Start date: April 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Procedure:
• Active 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
• Sham 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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	National Institute of Neurological Disorders and Stroke (NINDS), Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD motor scores measured by Kinesia HomeView	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.	Average change from two days before tDCS sleep study to two days after tDCS sleep study	No
Secondary	Sleepiness	Epworth Sleepiness Scale	Average change from two days before tDCS sleep study to two days after tDCS sleep study	No
Secondary	tDCS sensations	Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study.	Day after tDCS sleep studies	Yes
Secondary	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	No
Secondary	Overnight Polysomnography	Polysomnography parameters will be compared during the active and sham tDCS sleep studies.	During each sleep study	No