Clinical trial NCT02287207: Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Transcranial Direct Current Stimulation
Fine Motor Skills
Handwriting
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in writing amplitude
timeFrame: post-stimulation (immediately after) and retention (1 week)
measure: Change in writing velocity
timeFrame: post-stimulation (immediately after) and retention (1 week)
Secondary outcomes:
measure: Change in speed on the Purdue Pegboard task
timeFrame: post-stimulation (immediately after) and retention (1 week)
measure: Change in cortical excitability
timeFrame: post-stimulation (immediately after) and retention (1 week)
measure: Change in Short-Latency Intracortical Inhibition (SICI)
timeFrame: post-stimulation (immediately after) and retention (1 week)
measure: Change in cortical silent period (cSP)
timeFrame: post-stimulation (immediately after) and retention (1 week)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: CatholicULeuven
Study officials:
References:
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.
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.
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.