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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287207
• Other study ID #: S57231
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: June 6, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fine Motor Skills
• Handwriting
• Parkinson Disease
• Parkinson's Disease
• Transcranial Direct Current Stimulation

Intervention

Device:
• transcranial direct current stimulation (tDCS)

Locations

Country	Name	City	State
Belgium	CatholicULeuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in writing amplitude	Centimeter (cm)	post-stimulation (immediately after) and retention (1 week)	No
Primary	Change in writing velocity	Centimeter per second (cm/s)	post-stimulation (immediately after) and retention (1 week)	No
Secondary	Change in speed on the Purdue Pegboard task	Number of pegs placed in 30 seconds	post-stimulation (immediately after) and retention (1 week)	No
Secondary	Change in cortical excitability	Motor Evoked Potentials (MEP) peak to peak amplitude and latency - Measured with single-pulse Transcranial Magnetic	post-stimulation (immediately after) and retention (1 week)	No
Secondary	Change in Short-Latency Intracortical Inhibition (SICI)	Measured with double-pulse Transcranial Magnetic Stimulation (TMS)	post-stimulation (immediately after) and retention (1 week)	No
Secondary	Change in cortical silent period (cSP)	Measured with single-pulse Transcranial Magnetic	post-stimulation (immediately after) and retention (1 week)	No

External Links

•   Neuromotor Rehabilitation Research Group - KU Leuven, Belgium