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Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study

Primary Purpose

Parkinson's Disease, Transcranial Direct Current Stimulation, Fine Motor Skills

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Metal parts in the body
  • Any external or internal metal
  • Artificial heart valve
  • Other implants
  • History of brain surgery
  • Migraine
  • Family history of Epilepsy
  • Other contra-indications for tDCS and Transcranial Magnetic Stimulation (TMS)
  • Other neurological, psychiatric or interfering upper limb problems

Sites / Locations

  • CatholicULeuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Anodal tDCS

Sham tDCS

Arm Description

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

20 minutes, sham tDCS stimulation

Outcomes

Primary Outcome Measures

Change in writing amplitude
Centimeter (cm)
Change in writing velocity
Centimeter per second (cm/s)

Secondary Outcome Measures

Change in speed on the Purdue Pegboard task
Number of pegs placed in 30 seconds
Change in cortical excitability
Motor Evoked Potentials (MEP) peak to peak amplitude and latency - Measured with single-pulse Transcranial Magnetic
Change in Short-Latency Intracortical Inhibition (SICI)
Measured with double-pulse Transcranial Magnetic Stimulation (TMS)
Change in cortical silent period (cSP)
Measured with single-pulse Transcranial Magnetic

Full Information

First Posted
November 3, 2014
Last Updated
June 6, 2016
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02287207
Brief Title
Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

5. Study Description

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.
Detailed Description
The pilot study will involve a double-blind, sham controlled cross-over design where participants will receive anodal and sham tDCS stimulation in a randomized order. Differences in brain activity and fine motor skill performance between groups and after tDCS stimulation will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Transcranial Direct Current Stimulation, Fine Motor Skills, Handwriting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
20 minutes, 1.0 mA unilateral-anodal motor cortex (M1) tDCS stimulation
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
20 minutes, sham tDCS stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Primary Outcome Measure Information:
Title
Change in writing amplitude
Description
Centimeter (cm)
Time Frame
post-stimulation (immediately after) and retention (1 week)
Title
Change in writing velocity
Description
Centimeter per second (cm/s)
Time Frame
post-stimulation (immediately after) and retention (1 week)
Secondary Outcome Measure Information:
Title
Change in speed on the Purdue Pegboard task
Description
Number of pegs placed in 30 seconds
Time Frame
post-stimulation (immediately after) and retention (1 week)
Title
Change in cortical excitability
Description
Motor Evoked Potentials (MEP) peak to peak amplitude and latency - Measured with single-pulse Transcranial Magnetic
Time Frame
post-stimulation (immediately after) and retention (1 week)
Title
Change in Short-Latency Intracortical Inhibition (SICI)
Description
Measured with double-pulse Transcranial Magnetic Stimulation (TMS)
Time Frame
post-stimulation (immediately after) and retention (1 week)
Title
Change in cortical silent period (cSP)
Description
Measured with single-pulse Transcranial Magnetic
Time Frame
post-stimulation (immediately after) and retention (1 week)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Metal parts in the body Any external or internal metal Artificial heart valve Other implants History of brain surgery Migraine Family history of Epilepsy Other contra-indications for tDCS and Transcranial Magnetic Stimulation (TMS) Other neurological, psychiatric or interfering upper limb problems
Facility Information:
Facility Name
CatholicULeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24447597
Citation
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.
Results Reference
background
PubMed Identifier
23333265
Citation
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.
Results Reference
background
PubMed Identifier
26297812
Citation
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.
Results Reference
background
Links:
URL
http://gbiomed.kuleuven.be/english/research/50000743/nrrg1/nrrg.htm
Description
Neuromotor Rehabilitation Research Group - KU Leuven, Belgium

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Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study

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