Back to resultsElectrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
neuromuscular stimulation device
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Freezing of Gait, Gait, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
- A Hoehn and Yahr stage of 2 - 4
- Exhibiting Freezing of Gait or another gait abnormality in the ON state.
- An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state
Exclusion Criteria:
- A serious cognitive impairment (MMSE<24)
- Pregnant or currently involved in another clinical trial.
- Pacemakers
- On opioid or neuropathic pain medication
Sites / Locations
- Participants' home in the Mid-West region of Ireland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Freezing of Gait amelioration
Arm Description
Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration
Outcomes
Primary Outcome Measures
Percentage of Time in FoG PTF
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.
Number of FoG episodes occurring
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).
Secondary Outcome Measures
Full Information
NCT ID
NCT01970891
First Posted
October 19, 2013
Last Updated
September 16, 2020
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
University Hospital of Limerick
1. Study Identification
Unique Protocol Identification Number
NCT01970891
Brief Title
Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients
Official Title
Electrical Stimulation for the Relief of Freezing of Gait (FOG)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
University Hospital of Limerick
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)
Detailed Description
The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Freezing of Gait, Gait, Comfort, Pain tolerance, Pain, Sensory threshold, Motor threshold, Pain threshold
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Freezing of Gait amelioration
Arm Type
Experimental
Arm Description
Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration
Intervention Type
Device
Intervention Name(s)
neuromuscular stimulation device
Intervention Description
Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.
Primary Outcome Measure Information:
Title
Percentage of Time in FoG PTF
Description
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.
Time Frame
At time of intervention (seconds)
Title
Number of FoG episodes occurring
Description
We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).
Time Frame
At time of intervention (seconds)
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 Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
A Hoehn and Yahr stage of 2 - 4
Exhibiting Freezing of Gait or another gait abnormality in the ON state.
An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state
Exclusion Criteria:
A serious cognitive impairment (MMSE<24)
Pregnant or currently involved in another clinical trial.
Pacemakers
On opioid or neuropathic pain medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gearóid Ó Laighin, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Participants' home in the Mid-West region of Ireland
City
Limerick
ZIP/Postal Code
IRL
Country
Ireland
12. IPD Sharing Statement
Learn more about this trial
Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients
We'll reach out to this number within 24 hrs