Tonicity Monitor For Epilepsy and Hypertonic Disorders

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02110589
• Other study ID #: VIKEL CT001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: April 9, 2014
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2014
• Source: Vikel Ltd
• Contact: Mark Rees, PhD
• Phone: 01792 602203
• Email: m.i.rees[@]swansea.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Epidetect
Topically aplied muscle tonicity monitor (EMG recording)

Locations

Country	Name	City	State
United Kingdom	Morriston Hospital	Swansea

Sponsors (2)

Lead Sponsor	Collaborator
Vikel Ltd	Abertawe Bro Morgannwg University NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Using the device to reliably measure seizure frequency		2 years	No
Secondary	Using the device to reliably measure seizure duration		2 years	No
Secondary	Using the device to reliably measure strength of seizure		2 years	No