Parkinson's DiseaseNCT02287207
Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study
A study testing transcranial direct current stimulation (tDCS) in people with Parkinson's Disease and Transcranial Direct Current Stimulation, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Transcranial Direct Current Stimulation, Fine Motor Skills
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease, Transcranial Direct Current Stimulation, Fine Motor Skills, Handwriting
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Active comparator | 20 minutes, 1.0 mA unilateral-anodal motor cortex (M1) tDCS stimulation Receives: Device: transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | 20 minutes, sham tDCS stimulation Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in writing amplitude
Centimeter (cm)
Measured: post-stimulation (immediately after) and retention (1 week)
Change in writing velocity
Centimeter per second (cm/s)
Measured: post-stimulation (immediately after) and retention (1 week)
Secondary outcomes (4)
Change in speed on the Purdue Pegboard task
Number of pegs placed in 30 seconds
Measured: post-stimulation (immediately after) and retention (1 week)
Change in cortical excitability
Motor Evoked Potentials (MEP) peak to peak amplitude and latency - Measured with single-pulse Transcranial Magnetic
Measured: post-stimulation (immediately after) and retention (1 week)
Change in Short-Latency Intracortical Inhibition (SICI)
Measured with double-pulse Transcranial Magnetic Stimulation (TMS)
Measured: post-stimulation (immediately after) and retention (1 week)
Change in cortical silent period (cSP)
Measured with single-pulse Transcranial Magnetic
Measured: post-stimulation (immediately after) and retention (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287207
- Sponsor's protocol ID
- S57231
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
Publications
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.
PubMed 24447597Nackaerts 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.
PubMed 23333265Broeder 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.
PubMed 26297812
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Fine Motor Skills in Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT02287207
- Acronym / sponsor ID
- S57231
- Conditions
- Parkinson's Disease, Transcranial Direct Current Stimulation, Fine Motor Skills, Handwriting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Active comparator | Device: transcranial direct current stimulation (tDCS)20 minutes, 1.0 mA unilateral-anodal motor cortex (M1) tDCS stimulation |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS)20 minutes, sham tDCS stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | Anodal tDCS, Sham tDCS |
Primary outcome
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)
4 secondary outcomes
Change in speed on the Purdue Pegboard task
Time frame: post-stimulation (immediately after) and retention (1 week)
Change in cortical excitability
Time frame: post-stimulation (immediately after) and retention (1 week)
Change in Short-Latency Intracortical Inhibition (SICI)
Time frame: post-stimulation (immediately after) and retention (1 week)
Change in cortical silent period (cSP)
Time frame: post-stimulation (immediately after) and retention (1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Background: PubMed 24447597Broeder 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.
- Background: PubMed 23333265Nackaerts 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.
- Background: PubMed 26297812Broeder 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.
- Neuromotor Rehabilitation Research Group - KU Leuven, BelgiumLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Parkinson's Disease and Transcranial Direct Current Stimulation, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in writing amplitude (time frame: post-stimulation (immediately after) and retention (1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287207, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.