NCT02125383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

April 25, 2014

Last Update Submit

March 9, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseTranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Sleepiness

    Average change from two days before tDCS sleep study to two days after tDCS sleep study

  • tDCS sensations

    Day after tDCS sleep studies

  • 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

  • Overnight Polysomnography

    During each sleep study

Study Arms (2)

Active tDCS

EXPERIMENTAL

Receives 20 minutes of anodal tDCS three times while sleeping during the night.

Procedure: Active tDCS

Sham tDCS

SHAM COMPARATOR

Receives 20 minutes of sham tDCS three times while sleeping during the night.

Procedure: Sham tDCS

Interventions

Active tDCSPROCEDURE

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

Active tDCS
Sham tDCSPROCEDURE

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

Sham tDCS

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Dustin A Heldman, Ph.D.

    Great Lakes NeuroTechnologies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

US(1)