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

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Device: NMES Device comfort

• Registration Number: NCT01968473
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief Summary

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

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-09
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted QC: 2013-10-19
• Last Update Submitted: 2013-10-19
• Study First Posted: 2013-10-24
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.	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.

Trial Locations

Locations (1)

University Hospital Galway; 🇮🇪 Galway, Ireland