EpilepsyNCT02110589
Tonicity Monitor For Epilepsy and Hypertonic Disorders
A study testing Epidetect in people with Epilepsy, run by Vikel Ltd at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Epidetect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
- For PG-1 and PG-2 the persistence of intractable tonic-clonic epilepsy
- For PG-3 the clinical suspicion of dissociative seizures
- For PG-4 the clinical diagnosis of absence epilepsy
- For CG-1 the absence of neurological, muscular-skeletal disorders
- Suitable circumstances for informed consent in all instances
Who cannot join
- For Phase 1 of the trial:
- a diagnosis of a movement disorder
- For Phase 2 of the trial
- Where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in PG-2.
- Where neurological diagnosis is ambiguous or incomplete.
- Where topical application of the sensors causes discomfort or psychological distress.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Morriston Hospital
Swansea, SA6 6NL
Inder M Sawhney, MD, FRCP, Inder.Sawhney@wales.nhs.uk, Inder.Sawhney@wales.nhs.uk
Inder M Sawhney, MD, FRCP
About this study
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.
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.
- Conditions
- Epilepsy
- Being tested
- Epidetect
- Keywords
- seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidetectDevice
Topically aplied muscle tonicity monitor (EMG recording)
| Study group | Role | What they receive |
|---|---|---|
| Patient Group 1 | Experimental | 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. Receives: Device: Epidetect |
| Patient Group 2 | Experimental | 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. Receives: Device: Epidetect |
| Patient group 3 | Experimental | 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. Receives: Device: Epidetect |
| Patient Group 4 | Experimental | 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. Receives: Device: Epidetect |
| Control Group 1 | Other | 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. Receives: Device: Epidetect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Using the device to reliably measure seizure frequency
Measured: 2 years
Using the device to reliably measure seizure duration
Measured: 2 years
Using the device to reliably measure strength of seizure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vikel Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abertawe Bro Morgannwg University NHS Trust
- Responsible party
- Sponsor
- Investigators
- Inder M Sawhney, MD, FRCP, Principal investigator, Abertawe Bro Morgannwyg University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110589
- Sponsor's protocol ID
- VIKEL CT001
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02110589
- Acronym / sponsor ID
- VIKEL CT001
- Conditions
- Epilepsy
- Keywords
- seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Vikel LtdIndustry (pharma, biotech, devices)
- Collaborators
- Abertawe Bro Morgannwg University NHS Trust
- Study start
- Aug 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patient Group 1 | Experimental | Device: EpidetectTesting 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. |
| Patient Group 2 | Experimental | Device: EpidetectTesting 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. |
| Patient group 3 | Experimental | Device: EpidetectTesting 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. |
| Patient Group 4 | Experimental | Device: EpidetectTesting 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. |
| Control Group 1 | Other | Device: EpidetectTesting 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. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- For phase 1 of the trial; - admission to the neurophysiology department at Morriston hospital for in patient video telemetry
- For PG-1 and PG-2 the persistence of intractable tonic-clonic epilepsy
- For PG-3 the clinical suspicion of dissociative seizures
- For PG-4 the clinical diagnosis of absence epilepsy
- For CG-1 the absence of neurological, muscular-skeletal disorders
Key exclusion criteria (6 listed)
- a diagnosis of a movement disorder
- For Phase 2 of the trial
- Where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in PG-2.
- Where neurological diagnosis is ambiguous or incomplete.
- Where topical application of the sensors causes discomfort or psychological distress.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpidetectTopically aplied muscle tonicity monitor (EMG recording) | Device | Control Group 1, Patient Group 1, Patient Group 2, Patient Group 4, Patient group 3 |
Primary outcome
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.
3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inder M Sawhney, MD, FRCP principal investigator
Abertawe Bro Morgannwyg University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidetect in people with Epilepsy, run by Vikel Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Rees, PhD (01792 602203, m.i.rees@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurable changes in muscle tonicity specific to and discernable seizure activity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.