NCT02287207

Brief Summary

The purpose of this pilot study is to determine the effect of transcranial direct current stimulation (tDCS) on brain activity and fine motor skills in patients with Parkinson's disease compared to healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

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

First Submitted

Initial submission to the registry

November 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

November 3, 2014

Last Update Submit

June 6, 2016

Conditions

Parkinson's DiseaseTranscranial Direct Current StimulationFine Motor SkillsHandwriting

Outcome Measures

Primary Outcomes (2)

  • Change in writing amplitude

    Centimeter (cm)

    post-stimulation (immediately after) and retention (1 week)

  • Change in writing velocity

    Centimeter per second (cm/s)

    post-stimulation (immediately after) and retention (1 week)

Secondary Outcomes (4)

  • Change in speed on the Purdue Pegboard task

    post-stimulation (immediately after) and retention (1 week)

  • Change in cortical excitability

    post-stimulation (immediately after) and retention (1 week)

  • Change in Short-Latency Intracortical Inhibition (SICI)

    post-stimulation (immediately after) and retention (1 week)

  • Change in cortical silent period (cSP)

    post-stimulation (immediately after) and retention (1 week)

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

20 minutes, 1.0 mA unilateral-anodal motor cortex (M1) tDCS stimulation

Device: transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

20 minutes, sham tDCS stimulation

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS)DEVICE
Anodal tDCSSham tDCS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with idiopathic PD, according to the UK Brain Bank criteria
  • Hoehn and Yahr (H\&Y) stage II in the 'on'-phase of the medication cycle
  • Right dominant PD

You may not qualify if:

  • Cognitive impairment (MMSE \< 23)
  • Visuo-spatial deficits (measured by the Rey-Osterrieth Complex Figure (ROCF) test)
  • Left-handedness (evaluated by the Edinburgh Handedness scale)
  • Depression
  • Pregnancy
  • Alcohol abuse
  • Aneurysm clips
  • Pacemaker
  • Neurostimulator
  • Implemented defibrillator
  • Magnetically activated implant or device
  • Implemented pump
  • Spinal cord simulator
  • Implemented hearing aid
  • Artificial or prosthetic limb
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CatholicULeuven

Leuven, 3000, Belgium

Location

Related Publications (3)

  • Broeder S, Nackaerts E, Nieuwboer A, Smits-Engelsman BC, Swinnen SP, Heremans E. The effects of dual tasking on handwriting in patients with Parkinson's disease. Neuroscience. 2014 Mar 28;263:193-202. doi: 10.1016/j.neuroscience.2014.01.019. Epub 2014 Jan 19.

    PMID: 24447597BACKGROUND

  • Nackaerts E, Vervoort G, Heremans E, Smits-Engelsman BC, Swinnen SP, Nieuwboer A. Relearning of writing skills in Parkinson's disease: a literature review on influential factors and optimal strategies. Neurosci Biobehav Rev. 2013 Mar;37(3):349-57. doi: 10.1016/j.neubiorev.2013.01.015. Epub 2013 Jan 16.

    PMID: 23333265BACKGROUND

  • Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.

    PMID: 26297812BACKGROUND

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 10, 2014

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 8, 2016

Record last verified: 2015-11

Locations

BE(1)