Tonicity Monitor For Epilepsy and Hypertonic Disorders
NCT02110589 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2014-04-10
Summary
Epilepsy is an episodic disorder which can result in recurrent seizures often associated with hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). Hypertonia can often occur before full expression of the seizure and so detection of hypertonia could act as an alarm to epilepsy patients and carers in order to prepare for a seizure event. Secondly, a recording device for seizure frequency and duration is a valuable clinical tool for collecting data for clinicians who manage the disorder in primary and tertiary care. The investigators have developed a portable prototype for hypertonia detection using a non-invasive, muscle activated, sensor that records seizure activity. The investigators now want to test this sensor system in patients identified by Consultant Clinician Custodians within the Wales Epilepsy Research Network (WERN). The Epidetect® prototype has been developed by VIKEL LTD™ in collaboration with WERN - a Welsh Assembly funded network.
Conditions
Interventions
- DEVICE
-
Epidetect
Topically aplied muscle tonicity monitor (EMG recording)
Sponsors & Collaborators
-
Abertawe Bro Morgannwg University NHS Trust
collaborator OTHER_GOV -
Vikel Ltd
lead INDUSTRY
Principal Investigators
-
Inder M Sawhney, MD, FRCP · Abertawe Bro Morgannwyg University Health Board
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2017-01-31
- Completion
- 2017-01-31
Countries
- United Kingdom
Study Locations
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