Back to resultsComfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
NMES Device comfort
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring Parkinson's disease, Freezing of Gait, Neuromuscular Electrical Stimulation, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Uncontrolled heart problems
- Pacemakers
- On opioid or neuropathic pain medication
Sites / Locations
- University Hospital GalwayRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NMES Device comfort
Arm Description
NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01968473
First Posted
September 9, 2013
Last Updated
October 19, 2013
Sponsor
National University of Ireland, Galway, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT01968473
Brief Title
Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Freezing of Gait, Neuromuscular Electrical Stimulation, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NMES Device comfort
Arm Type
Experimental
Arm Description
NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established.
Intervention Type
Device
Intervention Name(s)
NMES Device comfort
Other Intervention Name(s)
Device name: Duo-Stim
Intervention Description
NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.
Primary Outcome Measure Information:
Title
Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
A serious cognitive impairment (MMSE<24)
Pregnant or currently involved in another clinical trial.
Uncontrolled heart problems
Pacemakers
On opioid or neuropathic pain medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Counihan, MD, FRCPI
Phone
0035391544251
Email
timothy.counihan@hse.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Browne, RGN, MHSc
Phone
0035391893833
Email
patrick.browne@hse.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gearoid O'Laighin, PhD
Organizational Affiliation
Electrical & Electronic Engineering NUI Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gearóid ÓLaighin, PhD
12. IPD Sharing Statement
Learn more about this trial
Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.
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