- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025401
Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2 (CAPAMETRIM2)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Grenoble, France, 38043
- Grenoble University Hospital Epilepsy Monitoring Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Proved generalized epilepsy
- No motor manifestations during seizures
- Pregnant women
- Subjects deprived of freedom by an administrative or judicial decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Motor manifestations during seizures
|
sensors are positioned on the right wrist, the left wrist and on the head.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3-D accelerometric and magnetic sensors
Time Frame: continuously during hospitalization recordings (46 Hz from 9 h to 17 h)
|
continuously during hospitalization recordings (46 Hz from 9 h to 17 h)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Video
Time Frame: continuously during hospitalization recordings (25 fps from 9 h to 17 h)
|
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)
|
continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Kahane, MD PHD, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0905
- 2009-A00196-51 (Registry Identifier: ID RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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