EpilepsyNCT01626599
Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data
A study testing ProGuardian in people with Epilepsy, run by Cyberonics, Inc. at 6 sites in United States.
Trial summary
This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- ProGuardian
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2012to Apr 2014
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria:
- Five (5) years of age or older
- Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits.
- Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization.
- A self-reported diagnosis of epilepsy.
- Currently taking at least one antiepileptic medication.
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- Caregivers must meet the following inclusion criteria:
- Eighteen (18) years of age or older
- Capable of understanding and willing to comply with instructions provided in english for proper use of the study device as well as scheduled study visits
- Willing and able to complete informed consent and HIPAA authorization.
Who cannot join
- Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria:
- Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
- History of chronic dermatological, medical, or physical conditions that would, in the investigators opinion, preclude topical application of the test products and/or influence the outcome of the test.
- Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
- An implanted defibrillator and/or pacemakers
- Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
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- Pregnant and or nursing women (verified by a urine pregnancy test).
- Currently participating in another clinical study without sponsor approval.
- Caregiver that is unable to read instructions in the English language.
- Under 18 years of age
- Not capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
United States, Texas
Austin, Texas, 78731
United States, North Carolina
Charlotte, North Carolina, 28209
United States, Illinois
Chicago, Illinois, 60654
United States, Texas
Houston, Texas, 77034
United States, Texas
Houston, Texas, 77054
United States, Texas
San Antonio, Texas, 78229
About this study
Official title: Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.
Read the detailed description
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
- Conditions
- Epilepsy
- Being tested
- ProGuardian
- Keywords
- ECG, Accelerometer, Device
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProGuardianDevice
The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights.
The investigational system:
- is not implantable and no surgical procedure is required for a human subject to use the devices;
- is not for use in supporting or sustaining a human life; and
- is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.
- Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.
| Study group | Role | What they receive |
|---|---|---|
| Assess product useability | Other | All subjects participate in the same arm. This arm completes the primary objective of product usability. Receives: Device: ProGuardian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess product useability
This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data.
Measured: Up to 7 nights/7 days
Secondary outcomes (1)
Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
Assess ECG and accelerometer data, device adhesion and dermal response
Measured: Up to 7 nights/7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionApr 2014
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Begnaud, Study director, Cyberonics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626599
- Sponsor's protocol ID
- PG-01
- Status last verified
- Jul 2020
- First submitted
- 15 Jun 2012
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data
- ClinicalTrials.gov ID
- NCT01626599
- Acronym / sponsor ID
- PG-01
- Conditions
- Epilepsy
- Keywords
- ECG, Accelerometer, Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jun 2012 (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.
This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.
Detailed description
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess product useability | Other | Device: ProGuardianAll subjects participate in the same arm. This arm completes the primary objective of product usability. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Five (5) years of age or older
- Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits.
- Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization.
- A self-reported diagnosis of epilepsy.
- Currently taking at least one antiepileptic medication.
Key exclusion criteria (11 listed)
- Subjects are not eligible to be enrolled in the study if they meet any of the following exclusion criteria:
- Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the ability to wear the patch.
- History of chronic dermatological, medical, or physical conditions that would, in the investigators opinion, preclude topical application of the test products and/or influence the outcome of the test.
- Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically applied products
- An implanted defibrillator and/or pacemakers
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 |
|---|---|---|
| ProGuardianThe investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: * is not implantable and no surgical procedure is required for a human subject to use the devices; * is not for use in supporting or sustaining a human life; and * is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. * Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles. | Device | Assess product useability |
Primary outcome
Assess product useability
Time frame: Up to 7 nights/7 days
This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data.
1 secondary outcome
Collect ECG and accelerometer data; device wearability; and evaluate adverse events.
Time frame: Up to 7 nights/7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
Jason Begnaud study director
Cyberonics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProGuardian in people with Epilepsy, run by Cyberonics, Inc. at 6 sites in United States.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess product useability (time frame: Up to 7 nights/7 days). 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 5 Aug 2020.