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

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Device: neuromuscular stimulation device

• Registration Number: NCT01970891
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief Summary

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

Detailed Description

The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2013-10-19
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Time in FoG PTF	At time of intervention (seconds)	We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the percentage of time in FoG.
Number of FoG episodes occurring	At time of intervention (seconds)	We hypothesise that the delivery of continuous sensory electrical stimulation will reduce the Number of FoG episodes Occurring (NFO).

Trial Locations

Locations (1)

Participants' home in the Mid-West region of Ireland; 🇮🇪 Limerick, Ireland