Tonicity Monitor For Epilepsy and Hypertonic Disorders

Vikel Ltd35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

Eligibility

Sex: ALLMin age: 7 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measurable changes in muscle tonicity specific to and discernable seizure activity

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.

Time frame: 2 years

Secondary Outcomes

Using the device to reliably measure seizure frequency

Time frame: 2 years

Using the device to reliably measure seizure duration

Time frame: 2 years

Using the device to reliably measure strength of seizure

Time frame: 2 years

Central Contacts

Mark Rees, PhD

CONTACT

01792 602203 m.i.rees@swansea.ac.uk

Cheney Drew, PhD

CONTACT

01792 602310 c.drew@swansea.ac.uk

Tonicity Monitor For Epilepsy and Hypertonic Disorders

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts