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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02287207
Other study ID # S57231
Secondary ID
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


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
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