Characterization of Epileptic Motor Patterns by Tridimens... | NCT01025401

Studies
Characterization of Epileptic Motor Patterns by Tridimensional Analysis of Movement 2

NCT01025401

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Nov 23, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Epileptic Patients With Motor Manifestations During Seizures

Interventions

3-D accelerometric and magnetic sensors

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00196-51	Registry Identifier	ID RCB

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

departure of a collaborator in charge of the data collection

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2010

Last Update Posted Date

Nov 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motor manifestations during seizures	No Intervention		Device: 3-D accelerometric and magnetic sensors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3-D accelerometric and magnetic sensors	Device	sensors are positioned on the right wrist, the left wrist and on the head.	Motor manifestations during seizures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3-D accelerometric and magnetic sensors		continuously during hospitalization recordings (46 Hz from 9 h to 17 h)

Secondary Outcomes

Measure	Description	Time Frame
Video		continuously during hospitalization recordings (25 fps from 9 h to 17 h)
EEG		continuously during hospitalization recordings (256-1024 Hz from 9 h to 17 h)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Kahane, MD PHD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grenoble University Hospital Epilepsy Monitoring Unit		Grenoble		38043	France

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D012640	Seizures

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided