Cortical Visual Impairment and Visual Attentiveness | NCT00342108

Studies
Cortical Visual Impairment and Visual Attentiveness

NCT00342108

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Nov 3, 2010Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Cerebral Palsy
Cortical Visual Impairment

Interventions

cross-modal sensory stimulation

Countries

Israel

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

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 21, 2006Estimated

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 2, 2010

Last Update Posted Date

Nov 3, 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

This study will investigate the effect of enhanced visual and cross-modal environments upon the visual attentiveness of multiply handicapped children diagnosed with Cerebral Palsy (CP) and Cortical Visual Impairment (CVI).

Research Hypothesis

Adapted visual environments which present controlled auditory, tactile, proprioceptive or contrasting visual background stimulation will enhance the visual attentiveness to a given visual stimulus of children diagnosed with CP and CVI.
Systematic, repetitive, visual stimulation over time, improves the visual attentiveness and/or visual-motor responses of CP-CVI children.
The analysis of additional behavioral responses to visual stimuli is a critical component in evaluating the perceptual development of visual attention in CP-CVI children.

Use of Noldus: The Observer, an advanced objective computerized observation program, will enable precise detection of the neurobehavioral responses of the participants. Both overt and covert responses will be observed, analyzed and correlated to identify the level of attention of each participant.

Detailed Description

Not provided

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Diagnosis: CP, moderate to severe MR and CVI	Behavioral: cross-modal sensory stimulation
2	Experimental	Diagnosis: CP, Moderate to severe MR, no visual impairment	Behavioral: cross-modal sensory stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cross-modal sensory stimulation	Behavioral	comparison of participant response to unimodal visual stimulation and to bimodal sensory stimulation	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Eye Movements		within the testing session

Secondary Outcomes

Measure	Description	Time Frame
Other behavioural responses		within the testing session

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

two to twelve years of age
diagnosis of: CP, mental retardation (MR) and CVI (Control group participants without visual disability)

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amichai Brezner, MD	Dept. of Pediatric Rehabilitation Sheba Medical Center Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba_Medical_Center		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D019575	Blindness, Cortical

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided