Tonicity Monitor For Epilepsy and Hypertonic Disorders

Not Applicable

• Conditions: Epilepsy

• Registration Number: NCT02110589
• Lead Sponsor: Vikel Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-09
• Study First Posted: 2014-04-10
• Last Update Posted: 2014-04-10
• Study Start: 2014-08
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurable changes in muscle tonicity specific to and discernable seizure activity	2 years	The primary outcome measure for the study will the development of a tonicity monitor that can successfully detect increases in muscle tonicity preceding a seizure event and alert the patient of an impending attack.

Secondary Outcome Measures

Name	Time	Method
Using the device to reliably measure seizure frequency	2 years
Using the device to reliably measure seizure duration	2 years
Using the device to reliably measure strength of seizure	2 years

Trial Locations

Locations (1)

Morriston Hospital; 🇬🇧 Swansea, United Kingdom