Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2020-12-04
2021-11-25
Brief Summary
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There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
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Detailed Description
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Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.
There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.
The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers.
Conditions
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Study Design
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NA
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Main
gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference.
geko™
Assess if cardiac pacemakers detect geko™ electrical output pulse.
Interventions
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geko™
Assess if cardiac pacemakers detect geko™ electrical output pulse.
Eligibility Criteria
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Inclusion Criteria
* Intact healthy skin at the site of geko™ device application.
* Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.
* Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
Exclusion Criteria
* Use of any concurrent use of a neuro-modulation device.
* Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)
* Participation in any other clinical study that may interfere with the outcome of either study
18 Years
ALL
No
Sponsors
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Firstkind Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Zaheer Yousef, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Wales, Cardiff
Locations
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University Hospital of Wales
Cardiff, , United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
Countries
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Other Identifiers
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FSK-CVD-003
Identifier Type: -
Identifier Source: org_study_id
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