Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:5 - Any
Updated:4/21/2016
Start Date:June 2012
End Date:April 2014

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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.

This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

1. Five (5) years of age or older

2. 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.

3. 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.

4. A self-reported diagnosis of epilepsy.

5. Currently taking at least one antiepileptic medication.

Caregivers must meet the following inclusion criteria:

1. Eighteen (18) years of age or older

2. 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

3. Willing and able to complete informed consent and HIPAA authorization.

Exclusion Criteria:

Subjects are not eligible to be enrolled in the study if they meet any of the following
exclusion criteria:

1. Any visible skin disorder, condition, or abnormal skin pigmentation which, in the
investigators opinion, would interfere with the ability to wear the patch.

2. 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.

3. Known sensitivity or history of irritation to adhesive tape (Latex) and/or topically
applied products

4. An implanted defibrillator and/or pacemakers

5. Severe psychiatric disease that in the investigator's judgment would prevent the
patient's successful completion of the study.

6. Pregnant and or nursing women (verified by a urine pregnancy test).

7. Currently participating in another clinical study without sponsor approval.

8. Caregiver that is unable to read instructions in the English language.

Exclusion Criteria for Caregiver:

1. Under 18 years of age

2. 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
We found this trial at
6
sites
Charlotte, North Carolina 28209
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Charlotte, NC
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Austin, Texas 78731
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Austin, TX
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Chicago, Illinois 60612
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Chicago, IL
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Houston, Texas 77054
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Houston, TX
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Houston, Texas 77054
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Houston, TX
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San Antonio, Texas 78229
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San Antonio, TX
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