Comfort and Tolerance of Surface Neuro Muscular Electrica... | NCT01968473

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

NCT01968473

Sponsor

National University of Ireland, Galway, Ireland

Status

Unknown status

Last Update Posted

Oct 24, 2013Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

NMES Device comfort

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Oct 19, 2013

First Posted Date

Oct 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2013

Last Update Posted Date

Oct 24, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gearoid O Laighin, Professor, National University of Ireland, Galway, IrelandPrincipal Investigator

Lead Sponsor

National University of Ireland, Galway, IrelandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NMES Device comfort	Experimental	NMES Device comfort, establishing Sensory, Motor and Pain thresholds. Max Pain tolerance is also established.	Device: NMES Device comfort

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NMES Device comfort	Device	NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.	NMES Device comfort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timothy Counihan, MD, FRCPI	Contact	0035391544251		timothy.counihan@hse.ie
Patrick Browne, RGN, MHSc	Contact	0035391893833		patrick.browne@hse.ie

Overall Officials

Name	Affiliation	Role
Gearoid O'Laighin, PhD	Electrical & Electronic Engineering NUI Galway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Galway	Recruiting	Galway			Ireland

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D010146	Pain

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided