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

NCT ID: NCT01968473

Last Updated: 2013-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease Freezing of Gait Neuromuscular Electrical Stimulation Comfort Pain tolerance Pain Sensory threshold Motor threshold Pain threshold

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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NMES Device comfort

NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established.

Group Type EXPERIMENTAL

NMES Device comfort

Intervention Type DEVICE

NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.

Interventions

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NMES Device comfort

NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.

Intervention Type DEVICE

Other Intervention Names

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Device name: Duo-Stim

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Gearoid O Laighin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gearoid O'Laighin, PhD

Role: PRINCIPAL_INVESTIGATOR

Electrical & Electronic Engineering NUI Galway

Locations

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University Hospital Galway

Galway, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Timothy Counihan, MD, FRCPI

Role: CONTACT

Phone: 0035391544251

Email: [email protected]

Patrick Browne, RGN, MHSc

Role: CONTACT

Phone: 0035391893833

Email: [email protected]

Other Identifiers

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NMES_PD_Comfort

Identifier Type: -

Identifier Source: org_study_id