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

Parkinson's Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01968473
• Other study ID #: NMES_PD_Comfort
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: October 19, 2013
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: National University of Ireland, Galway, Ireland
• Contact: Timothy Counihan, MD, FRCPI
• Phone: 0035391544251
• Email: timothy.counihan[@]hse.ie
• Is FDA regulated: No
• Health authority: Ireland: Health Service Executive
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• NMES Device comfort
NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.

Locations

Country	Name	City	State
Ireland	University Hospital Galway	Galway

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort in response to neuromuscular electrical stimulation in Parkinson's disease.	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	Yes