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Clinical Trials/NCT01970891
NCT01970891UnknownNot Applicable

Electrical Stimulation for the Relief of Freezing of Gait (FOG)

National University of Ireland, Galway, Ireland1 site in 1 country12 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
12
Locations
1
Primary Endpoint
Percentage of Time in FoG PTF

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Freezing of Gait amelioration

Experimental

Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration

Intervention: neuromuscular stimulation device (Device)

Outcomes

Primary Outcomes

Percentage of Time in FoG PTF

Time Frame: At time of intervention (seconds)

We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.

Number of FoG episodes occurring

Time Frame: At time of intervention (seconds)

We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gearoid O Laighin

Professor

National University of Ireland, Galway, Ireland

Study Sites (1)

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