Parkinson's DiseaseNCT01968473
Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.
A study testing NMES Device comfort in people with Parkinson's Disease, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
The purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- NMES Device comfort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2013to Oct 2013
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of idiopathic PD (UK, PD Brain Bank Criteria)
- A Hoehn and Yahr stage of 2 - 4
- Exhibiting Freezing of Gait or another gait abnormalityin the ON or OFF state.
- An ability to mobilise independently for the purpose of research when in the 'off' state
- An ability to walk unaided for 10 meters.
Who cannot join
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Uncontrolled heart problems
- Pacemakers
- On opioid or neuropathic pain medication
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway
Gearóid ÓLaighin, PhD
About this study
Official title: An Evaluation of Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation (NMES), When Applied to Parkinson's Disease Patients for Both Sensory and Motor Activation.
The purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.
Read the detailed description
The comfort and tolerance of Parkinson Disease (PD) patients to surface neuro muscular electrical stimulation (NMES) will be investigated.
Six muscle sites will be tested sensory, motor and pain thresholds recorded. Furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.
- Conditions
- Parkinson's Disease
- Being tested
- NMES Device comfort
- Keywords
- Parkinson's disease, Freezing of Gait, Neuromuscular Electrical Stimulation, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
- Medical subject headings
- Parkinson Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES Device comfortDevice
Also called Device name: Duo-Stim
NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.
| Study group | Role | What they receive |
|---|---|---|
| NMES Device comfort | Experimental | NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established. Receives: Device: NMES Device comfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.
Participants will be tested over a range of stimulation intensities at different muscle sites. Primary outcome measure will be patient comfort and tolerance to neuromuscular electrical stimulation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gearoid O Laighin, National University of Ireland, Galway, Ireland
- Investigators
- Gearoid O'Laighin, PhD, Principal investigator, Electrical & Electronic Engineering NUI Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968473
- Sponsor's protocol ID
- NMES_PD_Comfort
- Status last verified
- Oct 2013
- First submitted
- 9 Sep 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation (NMES), When Applied to Parkinson's Disease Patients for Both Sensory and Motor Activation.
- ClinicalTrials.gov ID
- NCT01968473
- Acronym / sponsor ID
- NMES_PD_Comfort
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Freezing of Gait, Neuromuscular Electrical Stimulation, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Oct 2013 (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 study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.
Detailed description
The comfort and tolerance of Parkinson Disease (PD) patients to surface neuro muscular electrical stimulation (NMES) will be investigated.
Six muscle sites will be tested sensory, motor and pain thresholds recorded. Furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMES Device comfort | Experimental | Device: NMES Device comfortNMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of idiopathic PD (UK, PD Brain Bank Criteria)
- A Hoehn and Yahr stage of 2 - 4
- Exhibiting Freezing of Gait or another gait abnormalityin the ON or OFF state.
- An ability to mobilise independently for the purpose of research when in the 'off' state
- An ability to walk unaided for 10 meters.
Key exclusion criteria (5 listed)
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Uncontrolled heart problems
- Pacemakers
- On opioid or neuropathic pain medication
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 |
|---|---|---|
| NMES Device comfortAlso: Device name: Duo-StimNMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance. | Device | NMES Device comfort |
Primary outcome
Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.
Time frame: 1 day
Participants will be tested over a range of stimulation intensities at different muscle sites. Primary outcome measure will be patient comfort and tolerance to neuromuscular electrical stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
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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.
Gearoid O'Laighin, PhD principal investigator
Electrical & Electronic Engineering NUI Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES Device comfort in people with Parkinson's Disease, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Oct 2013. 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 Ireland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy Counihan, MD, FRCPI (0035391544251, timothy.counihan@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2013.