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.

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 Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Device: Epidetect

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Group 1; Testing of Epidetect: Adult Patients with difficult to control tonic-clonic (convulsant) epilepsy undergoing hospitalised video telemetry monitoring. Patients will be hospitalised as part of their normal investigation of the epilepsy and patients will be consented 1 week before hospitalisation. Epidetect will be used in conjunction with the normal EEG monotoring and video telemetry. The patient will be fitted with the topical sensors at the start of monotoring and then depending on the seizure activity will wear the sensors until enough data is gathered. Hospitalisation under these circumstances typically lasts no more than five days, so monitoring with the topical sensor will be no longer than this.	Device: Epidetect; Topically aplied muscle tonicity monitor (EMG recording)
Experimental: Patient Group 2; Testing of Epidetect: Paediatric patients (over 7 years) where parental consent will enable the epilepsy monitor to be used at home for 1 week and brought back in for analysis along with video evidence. This will not constitute any change in normal care or treatments, and the video evidence provided represents enhanced care through accurate seizure diary reporting. Suitable families and children will be selected and consented through scheduled clinics in paediatric neurology.	Device: Epidetect; Topically aplied muscle tonicity monitor (EMG recording)
Experimental: Patient group 3; Testing of Epidetect: Patients where the epilepsy is suspected to be psychogenic (pseudo-seizures) rather than organic epilepsy. We will test whether the epilepsy monitor will be able to differentiate between epilepsy and psychogenic seizures in the medical setting when patients are hospitlised for seizure investigation. Suitable patients will be selected and consented through scheduled clinics in paediatric neurology (under 16) and adult neurology.	Device: Epidetect; Topically aplied muscle tonicity monitor (EMG recording)
Experimental: Patient Group 4; Testing of Epidetect: Internal negative Controls. Juveniles or adults with other forms of epilepsy that do not have a hypertonic (increased muscle stiffening) phenotype e.g. absence seizures.	Device: Epidetect; Topically aplied muscle tonicity monitor (EMG recording)
Other: Control Group 1; Testing of Epidetect: Volunteers who do not have a history of seizures / epielsy, head trauma, migraine, neurological or muscular-skeletal disorders. This is to produce the baseline data for the Monitor.	Device: Epidetect; Topically aplied muscle tonicity monitor (EMG recording)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Vikel Ltd
• Collaborators: Abertawe Bro Morgannwg University NHS Trust
• Investigators: Principal Investigator: Inder M Sawhney, MD, FRCP, Abertawe Bro Morgannwyg University Health Board

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: VIKEL CT001