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Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2 (CAPAMETRIM2)

Primary Purpose

Epileptic Patients With Motor Manifestations During Seizures

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3-D accelerometric and magnetic sensors
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epileptic Patients With Motor Manifestations During Seizures focused on measuring epilepsy, seizures, movement

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grenoble University Hospital Epilepsy Monitoring Unit

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Motor manifestations during seizures

Arm Description

Outcomes

Primary Outcome Measures

3-D accelerometric and magnetic sensors

Secondary Outcome Measures

Video
EEG

Full Information

First Posted
June 29, 2009
Last Updated
November 22, 2010
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01025401
Brief Title
Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2
Acronym
CAPAMETRIM2
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
departure of a collaborator in charge of the data collection
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epileptic Patients With Motor Manifestations During Seizures
Keywords
epilepsy, seizures, movement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor manifestations during seizures
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
3-D accelerometric and magnetic sensors
Intervention Description
sensors are positioned on the right wrist, the left wrist and on the head.
Primary Outcome Measure Information:
Title
3-D accelerometric and magnetic sensors
Time Frame
continuously during hospitalization recordings (46 Hz from 9 h to 17 h)
Secondary Outcome Measure Information:
Title
Video
Time Frame
continuously during hospitalization recordings (25 fps from 9 h to 17 h)
Title
EEG
Time Frame
continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Kahane, MD PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital Epilepsy Monitoring Unit
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

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Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2

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