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Clinical Trials/NCT01025401
NCT01025401TerminatedNot Applicable

Caractérisation et détection Des Mouvements Durant Les Crises d'épilepsie à Des Fins d'Alarme, Pour un Usage en Institution et en Famille.

University Hospital, Grenoble2 sites in 1 country50 target enrollmentStarted: May 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
3-D accelerometric and magnetic sensors

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

3-D accelerometric and magnetic sensors

Time Frame: continuously during hospitalization recordings (46 Hz from 9 h to 17 h)

Secondary Outcomes

  • EEG(continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h))
  • Video(continuously during hospitalization recordings (25 fps from 9 h to 17 h))

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other

Study Sites (2)

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