Epileptic Patients With Motor Manifestations During SeizuresCAPAMETRIM2NCT01025401
Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2
A study testing 3-D accelerometric and magnetic sensors in people with Epileptic Patients With Motor Manifestations During Seizures, run by University Hospital, Grenoble at 1 site in France.
Trial summary
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements. This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows their detection with an ambulatory monitoring system. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epileptic Patients With Motor Manifestations During Seizures
- What is being tested?
- 3-D accelerometric and magnetic sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Oct 2010
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult or children (>= 6 years)
- Written inform consented from the patient or its legal representative
- Presurgical investigation of pharmaco-resistant partial epilepsy
- Motor manifestations during seizures
Who cannot join
- Proved generalized epilepsy
- No motor manifestations during seizures
- Pregnant women
- Subjects deprived of freedom by an administrative or judicial decision
Trial locations and contacts
1 site in 1 country.
France1 site
Grenoble University Hospital Epilepsy Monitoring Unit
Grenoble, 38043
About this study
Official title: Caractérisation et détection Des Mouvements Durant Les Crises d'épilepsie à Des Fins d'Alarme, Pour un Usage en Institution et en Famille.
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.
This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows their detection with an ambulatory monitoring system.
The benefit for patients is to improve the diagnosis of their diseases by better characterizing their seizures.
Read the detailed description
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.
The project is planned in three phases:
- Installation of 3-D accelerometric and magnetic sensors acquisition systems on the hospital (extension of a preceding study CAPAMETRIM).
- Collection of data on epileptic patients. Sensors will be positioned on the right and left hands and on the head. A 3-D analysis of movements will be done according to the collection by tagging data with visual analysis made on video.
- Development of a motor pattern classification system used for seizure detection.
- Being tested
- 3-D accelerometric and magnetic sensors
- Keywords
- epilepsy, seizures, movement
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D accelerometric and magnetic sensorsDevice
sensors are positioned on the right wrist, the left wrist and on the head.
| Study group | Role | What they receive |
|---|---|---|
| Motor manifestations during seizures | No intervention | Not described Receives: Device: 3-D accelerometric and magnetic sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-D accelerometric and magnetic sensors
Measured: continuously during hospitalization recordings (46 Hz from 9 h to 17 h)
Secondary outcomes (2)
Video
Measured: continuously during hospitalization recordings (25 fps from 9 h to 17 h)
EEG
Measured: continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: departure of a collaborator in charge of the data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic Patients With Motor Manifestations During SeizuresStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Kahane, MD PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025401
- Sponsor's protocol ID
- 0905
- Other IDs
- 2009-A00196-51
- Acronym
- CAPAMETRIM2
- Status last verified
- Nov 2010
- First submitted
- 29 Jun 2009
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caractérisation et détection Des Mouvements Durant Les Crises d'épilepsie à Des Fins d'Alarme, Pour un Usage en Institution et en Famille.
- ClinicalTrials.gov ID
- NCT01025401
- Acronym / sponsor ID
- CAPAMETRIM2 / 0905
- Keywords
- epilepsy, seizures, movement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of a collaborator in charge of the data collection
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Dec 2009 (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.
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.
This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows their detection with an ambulatory monitoring system.
The benefit for patients is to improve the diagnosis of their diseases by better characterizing their seizures.
Detailed description
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.
The project is planned in three phases:
- Installation of 3-D accelerometric and magnetic sensors acquisition systems on the hospital (extension of a preceding study CAPAMETRIM).
- Collection of data on epileptic patients. Sensors will be positioned on the right and left hands and on the head. A 3-D analysis of movements will be done according to the collection by tagging data with visual analysis made on video.
- Development of a motor pattern classification system used for seizure detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor manifestations during seizures | No intervention | Device: 3-D accelerometric and magnetic sensors |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult or children (>= 6 years)
- Written inform consented from the patient or its legal representative
- Presurgical investigation of pharmaco-resistant partial epilepsy
- Motor manifestations during seizures
Key exclusion criteria (4 listed)
- Proved generalized epilepsy
- No motor manifestations during seizures
- Pregnant women
- Subjects deprived of freedom by an administrative or judicial decision
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 |
|---|---|---|
| 3-D accelerometric and magnetic sensorssensors are positioned on the right wrist, the left wrist and on the head. | Device | Motor manifestations during seizures |
Primary outcome
3-D accelerometric and magnetic sensors
Time frame: continuously during hospitalization recordings (46 Hz from 9 h to 17 h)
2 secondary outcomes
Video
Time frame: continuously during hospitalization recordings (25 fps from 9 h to 17 h)
EEG
Time frame: continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)
Results and safety
The study was stopped early (reason given: departure of a collaborator in charge of the data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
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.
Philippe Kahane, MD PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D accelerometric and magnetic sensors in people with Epileptic Patients With Motor Manifestations During Seizures, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Nov 2010. 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 France. 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 was stopped early (reason given: departure of a collaborator in charge of the data collection). Results are not available in the source record.
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?
3-D accelerometric and magnetic sensors (time frame: continuously during hospitalization recordings (46 Hz from 9 h to 17 h)). 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 23 Nov 2010.