Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients

September 16, 2020 updated by: Gearoid O Laighin, National University of Ireland, Galway, Ireland

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

Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland, IRL
        • Participants' home in the Mid-West region of Ireland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freezing of Gait amelioration
Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration
Device: neuromuscular stimulation device
Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time of intervention (seconds)
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).
At time of intervention (seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Ireland, Galway, Ireland

Collaborators

University Hospital of Limerick

Investigators

  • Principal Investigator: Gearóid Ó Laighin, PhD, National University of Ireland, Galway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

October 19, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES_PD_S_FOG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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