EpilepsyNCT01850498
Epilepsy Motion Sensing
An observational study of Epilepsy, run by MedtronicNeuro at 1 site in United States.
Trial summary
Evaluate patient motion during seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epilepsy referred to epilepsy monitoring unit.
Who may be able to join
- 18 years of age or older
- Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
- Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
- Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
- Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
- Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
- Male or non-pregnant female
- English speaking
Who cannot join
- Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
- Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
- Have a movement disorder that may affect GT3X+ recordings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motion Sensing Study in Epilepsy Patients
Evaluate patient motion during seizures.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizure, Motor, Motion, Accelerometer
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Partial seizures | Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior | |
| Generalized seizures | Primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings).
Measured: While patients are being evaluated in an epilepsy monitoring unit.
Secondary outcomes (3)
Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings).
Measured: While patients are being evaluated in an epilepsy monitoring unit.
Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings).
Measured: While patients are being evaluated in an epilepsy monitoring unit.
Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings).
Measured: While patients are being evaluated in an epilepsy monitoring unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850498
- Sponsor's protocol ID
- 1663
- Status last verified
- May 2013
- First submitted
- 1 Nov 2012
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Sensing Study in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT01850498
- Acronym / sponsor ID
- 1663
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Seizure, Motor, Motion, Accelerometer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 May 2013 (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.
Evaluate patient motion during seizures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial seizures | – | –Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior |
| Generalized seizures | – | –Primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epilepsy referred to epilepsy monitoring unit.
Key inclusion criteria (8 listed)
- 18 years of age or older
- Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
- Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
- Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
- Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
Key exclusion criteria (3 listed)
- Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
- Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
- Have a movement disorder that may affect GT3X+ recordings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings).
Time frame: While patients are being evaluated in an epilepsy monitoring unit.
3 secondary outcomes
Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings).
Time frame: While patients are being evaluated in an epilepsy monitoring unit.
Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings).
Time frame: While patients are being evaluated in an epilepsy monitoring unit.
Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings).
Time frame: While patients are being evaluated in an epilepsy monitoring unit.
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 9 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by MedtronicNeuro at 1 site 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 8 inclusion and 3 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 9 May 2013. 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 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?
To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings). (time frame: While patients are being evaluated in an epilepsy monitoring unit.). 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 9 May 2013.