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

NCT01968473 | Unknown DMC

• 1 other identifier: NMES_PD_Comfort
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NMES Device comfort

EXPERIMENTAL

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

Device: NMES Device comfort

Interventions

NMES Device comfort DEVICE

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

Also known as: Device name: Duo-Stim

NMES Device comfort

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A serious cognitive impairment (MMSE\<24)
• Pregnant or currently involved in another clinical trial.
• Uncontrolled heart problems
• Pacemakers
• On opioid or neuropathic pain medication

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Pain

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gearoid O'Laighin, PhD

  Electrical & Electronic Engineering NUI Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy Counihan, MD, FRCPI

CONTACT

0035391544251; timothy.counihan@hse.ie

Patrick Browne, RGN, MHSc

CONTACT

0035391893833; patrick.browne@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: October 24, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

IE (1)