Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients

NCT01970891 | Unknown DMC

• 1 other identifier: NMES_PD_S_FOG
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)

Conditions

Parkinson's Disease

Keywords

Freezing of Gait; Gait; Comfort; Pain tolerance; Pain; Sensory threshold; Motor threshold; Pain threshold

Outcome Measures

Primary Outcomes (2)

• Percentage of Time in FoG PTF

  We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.

  At time of intervention (seconds)

• Number of FoG episodes occurring

  We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).

  At time of intervention (seconds)

Study Arms (1)

Freezing of Gait amelioration

EXPERIMENTAL

Effect of neuromuscular stimulation device will be assessed on Freezing of Gait amelioration

Device: neuromuscular stimulation device

Interventions

neuromuscular stimulation device DEVICE

Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.

Freezing of Gait amelioration

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 Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
• A Hoehn and Yahr stage of 2 - 4
• Exhibiting Freezing of Gait or another gait abnormality in the ON state.
• An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state

You may not qualify if:

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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• University Hospital of Limerick: collaborator

Study Sites (1)

Participants' home in the Mid-West region of Ireland

Limerick, IRL, Ireland

Location

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

• Gearóid Ó Laighin, PhD

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.

Study Record Dates

• First Submitted: October 19, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

IE (1)