Clinical trial NCT02110589: Tonicity Monitor For Epilepsy and Hypertonic Disorders
Official title: Investigation Into the Efficacy and Application of Non-invasive Sensor Technology to Produce a Community-based Seizure Alarm/Monitor for Epilepsy and Episodic Hyperexcitability Disorders.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: seizures
Lead sponsor: Vikel Ltd
Sponsor class: INDUSTRY
Collaborators: name: Abertawe Bro Morgannwg University NHS Trust
First posted: 2014-04-10
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: Inclusion Criteria:

For phase 1 of the trial; - admission to the neurophysiology department at Morriston hospital for in patient video telemetry

For Phase 2 of the trial:

1. For PG-1 and PG-2 the persistence of intractable tonic-clonic epilepsy
2. For PG-3 the clinical suspicion of dissociative seizures
3. For PG-4 the clinical diagnosis of absence epilepsy
4. For CG-1 the absence of neurological, muscular-skeletal disorders
5. Suitable circumstances for informed consent in all instances

Exclusion Criteria:

For Phase 1 of the trial:

- a diagnosis of a movement disorder

For Phase 2 of the trial

1. Where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in PG-2.
2. Where neurological diagnosis is ambiguous or incomplete.
3. Where topical application of the sensors causes discomfort or psychological distress.

Primary outcomes:
measure: Measurable changes in muscle tonicity specific to and discernable seizure activity
timeFrame: 2 years
Secondary outcomes:
measure: Using the device to reliably measure seizure frequency
timeFrame: 2 years
measure: Using the device to reliably measure seizure duration
timeFrame: 2 years
measure: Using the device to reliably measure strength of seizure
timeFrame: 2 years
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Morriston Hospital
Study officials:
affiliation: Abertawe Bro Morgannwyg University Health Board
name: Inder M Sawhney, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: