Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2

Epileptic Patients With Motor Manifestations During Seizures Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01025401
• Other study ID #: 0905
• Secondary ID: 2009-A00196-51
• Status: Terminated
• Phase: N/A
• First received: June 29, 2009
• Last updated: November 22, 2010
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

The benefit for patients is to improve the diagnosis of their diseases by better characterizing their seizures.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy
• Epileptic Patients With Motor Manifestations During Seizures

Intervention

Device:
• 3-D accelerometric and magnetic sensors
sensors are positioned on the right wrist, the left wrist and on the head.

Locations

Country	Name	City	State
France	Grenoble University Hospital Epilepsy Monitoring Unit	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-D accelerometric and magnetic sensors		continuously during hospitalization recordings (46 Hz from 9 h to 17 h)	No
Secondary	Video		continuously during hospitalization recordings (25 fps from 9 h to 17 h)	No
Secondary	EEG		continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)	No