Comfort and Tolerance of Surface Neuro Muscular Electrical Stimulation in Parkinson's Disease.

October 19, 2013 updated by: Gearoid O Laighin, National University of Ireland, Galway, Ireland

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

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
      • Galway, Ireland
        • Recruiting
        • University Hospital Galway
        • Principal Investigator:
          • Gearóid ÓLaighin, PhD

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 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

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMES Device comfort
NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established.
Device: NMES Device comfort
NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.
Other Names:
  • Device name: Duo-Stim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

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

Sponsor

National University of Ireland, Galway, Ireland

Investigators

  • Principal Investigator: Gearoid O'Laighin, PhD, Electrical & Electronic Engineering NUI 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

September 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

October 19, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

October 19, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES_PD_Comfort

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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