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Tonicity Monitor For Epilepsy and Hypertonic Disorders

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ClinicalTrials.gov Identifier: NCT02110589
Recruitment Status : Unknown
Verified April 2014 by Vikel Ltd.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Collaborator:
Abertawe Bro Morgannwg University NHS Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Epidetect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.
Study Start Date : August 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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)

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)




Primary Outcome Measures :
  1. Measurable changes in muscle tonicity specific to and discernable seizure activity [ Time Frame: 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 :
  1. Using the device to reliably measure seizure frequency [ Time Frame: 2 years ]
  2. Using the device to reliably measure seizure duration [ Time Frame: 2 years ]
  3. Using the device to reliably measure strength of seizure [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110589


Contacts
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Contact: Mark Rees, PhD 01792 602203 m.i.rees@swansea.ac.uk
Contact: Cheney Drew, PhD 01792 602310 c.drew@swansea.ac.uk

Locations
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United Kingdom
Morriston Hospital Not yet recruiting
Swansea, United Kingdom, SA6 6NL
Contact: Inder M Sawhney, MD, FRCP    Inder.Sawhney@wales.nhs.uk    Inder.Sawhney@wales.nhs.uk   
Principal Investigator: Inder M Sawhney, MD, FRCP         
Sub-Investigator: Cathy White, MB, FRCP         
Sub-Investigator: Soren Raasch, MD. FRCP         
Sponsors and Collaborators
Vikel Ltd
Abertawe Bro Morgannwg University NHS Trust
Investigators
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Principal Investigator: Inder M Sawhney, MD, FRCP Abertawe Bro Morgannwyg University Health Board

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Responsible Party: Vikel Ltd
ClinicalTrials.gov Identifier: NCT02110589     History of Changes
Other Study ID Numbers: VIKEL CT001
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Vikel Ltd:
seizures
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases