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Completed

NCT Number: NCT02287207

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Primary outcomes

  1. Change in writing amplitude

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Centimeter (cm)

  2. Change in writing velocity

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Centimeter per second (cm/s)

Secondary outcomes

  1. Change in speed on the Purdue Pegboard task

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Number of pegs placed in 30 seconds

  2. Change in cortical excitability

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Motor Evoked Potentials (MEP) peak to peak amplitude and latency - Measured with single-pulse Transcranial Magnetic

  3. Change in Short-Latency Intracortical Inhibition (SICI)

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Measured with double-pulse Transcranial Magnetic Stimulation (TMS)

  4. Change in cortical silent period (cSP)

    Time frame: post-stimulation (immediately after) and retention (1 week)

    Measured with single-pulse Transcranial Magnetic

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2014
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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