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

This study has been terminated.
(departure of a collaborator in charge of the data collection)
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01025401
First received: June 29, 2009
Last updated: November 22, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Epileptic Patients With Motor Manifestations During Seizures
Device: 3-D accelerometric and magnetic sensors

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 3-D accelerometric and magnetic sensors [ Time Frame: continuously during hospitalization recordings (46 Hz from 9 h to 17 h) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Video [ Time Frame: continuously during hospitalization recordings (25 fps from 9 h to 17 h) ] [ Designated as safety issue: No ]
  • EEG [ Time Frame: continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Motor manifestations during seizures Device: 3-D accelerometric and magnetic sensors
sensors are positioned on the right wrist, the left wrist and on the head.

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.
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025401

Locations
France
Grenoble University Hospital Epilepsy Monitoring Unit
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Philippe Kahane, MD PHD University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: Philippe KAHANE/MD-PHD, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01025401     History of Changes
Other Study ID Numbers: 0905, 2009-A00196-51
Study First Received: June 29, 2009
Last Updated: November 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
epilepsy
seizures
movement

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014