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

November 22, 2010 updated by: University Hospital, Grenoble

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

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Grenoble, France, 38043
        • Grenoble University Hospital Epilepsy Monitoring Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philippe Kahane, MD PHD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

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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