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

June 6, 2016 updated by: Alice Nieuwboer, KU Leuven
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • CatholicULeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anodal tDCS
20 minutes, 1.0 mA unilateral-anodal motor cortex (M1) tDCS stimulation
Device: transcranial direct current stimulation (tDCS)
Sham Comparator: Sham tDCS
20 minutes, sham tDCS stimulation
Device: transcranial direct current stimulation (tDCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in writing amplitude
Time Frame: post-stimulation (immediately after) and retention (1 week)
Centimeter (cm)
post-stimulation (immediately after) and retention (1 week)
Change in writing velocity
Time Frame: post-stimulation (immediately after) and retention (1 week)
Centimeter per second (cm/s)
post-stimulation (immediately after) and retention (1 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
post-stimulation (immediately after) and retention (1 week)
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
post-stimulation (immediately after) and retention (1 week)
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)
post-stimulation (immediately after) and retention (1 week)
Change in cortical silent period (cSP)
Time Frame: post-stimulation (immediately after) and retention (1 week)
Measured with single-pulse Transcranial Magnetic
post-stimulation (immediately after) and retention (1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S57231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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