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Clinical Trials/NCT02287207
NCT02287207CompletedNot Applicable

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

KU Leuven1 site in 1 country20 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
KU Leuven
Enrollment
20
Locations
1
Primary Endpoint
Change in writing amplitude

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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
  • •Family history of Epilepsy
  • •Other contra-indications for tDCS and Transcranial Magnetic Stimulation (TMS)
  • •Other neurological, psychiatric or interfering upper limb problems

Arms & Interventions

Anodal tDCS

Active Comparator

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

Intervention: transcranial direct current stimulation (tDCS) (Device)

Sham tDCS

Sham Comparator

20 minutes, sham tDCS stimulation

Intervention: transcranial direct current stimulation (tDCS) (Device)

Outcomes

Primary Outcomes

Change in writing amplitude

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

Centimeter (cm)

Change in writing velocity

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

Centimeter per second (cm/s)

Secondary Outcomes

  • Change in cortical silent period (cSP)(post-stimulation (immediately after) and retention (1 week))
  • 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))

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alice Nieuwboer

Professor

KU Leuven

Study Sites (1)

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