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

Parkinson's Disease Clinical Trial

Official title:

Electrical Stimulation for the Relief of Freezing of Gait (FOG)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01970891
• Other study ID #: NMES_PD_S_FOG
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Ireland	Participants' home in the Mid-West region of Ireland	Limerick

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	University Hospital of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)