Tonicity Monitor For Epilepsy and Hypertonic Disorders

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02110589

Enrollment

Registered

2014-04-10

Start date

2014-08-31

Completion date

2017-01-31

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

seizures

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.

Interventions

DEVICEEpidetect

Topically aplied muscle tonicity monitor (EMG recording)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United Kingdom

Contacts

Primary ContactMark Rees, PhD

m.i.rees@swansea.ac.uk01792 602203

Backup ContactCheney Drew, PhD

c.drew@swansea.ac.uk01792 602310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026