Rehabilitation Glasses for the Treatment of Hemispatial Neglect

May 7, 2018 updated by: Chun Lim
This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146).

Exclusion Criteria:

  • Presence of aphasia at time of testing,
  • Recent seizures
  • Major psychiatric illness
  • Prior unrelated neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic
Crossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect
Device: Computer rehabilitation glasses
Experimental: Acute
Randomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect
Device: Computer rehabilitation glasses
Experimental: Optimization
Study to identify optimal operating parameters of computer rehabilitation glasses
Device: Computer rehabilitation glasses
Active Comparator: Duration
Study to determine duration of effect of computer rehabilitation glasses
Device: Computer rehabilitation glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of patient's hemispatial neglect scores
Time Frame: 60 days
Behavioral Inattention Test
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chun Lim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

March 26, 2018

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P000297

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared upon publication of the data. Other researchers can contact PI to request this data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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