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

NCT ID: NCT02287207

Last Updated: 2016-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anodal tDCS

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

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Sham tDCS

20 minutes, sham tDCS stimulation

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alice Nieuwboer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CatholicULeuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24447597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23333265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26297812 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://gbiomed.kuleuven.be/english/research/50000743/nrrg1/nrrg.htm

Neuromotor Rehabilitation Research Group - KU Leuven, Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S57231

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tDCS as Treatment for Motor Function
NCT07291687 RECRUITING NA
tDCS on Parkinson's Disease Cognition
NCT03025334 RECRUITING NA