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Rehabilitation Glasses for the Treatment of Hemispatial Neglect

Primary Purpose

Hemispatial Neglect

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Computer rehabilitation glasses

About this trial

This is an interventional treatment trial for Hemispatial Neglect

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Chronic

Acute

Optimization

Duration

Arm Description

Crossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect

Randomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect

Study to identify optimal operating parameters of computer rehabilitation glasses

Study to determine duration of effect of computer rehabilitation glasses

Outcomes

Primary Outcome Measures

Improvement of patient's hemispatial neglect scores

Behavioral Inattention Test

Secondary Outcome Measures

Full Information

NCT ID

NCT02695927

First Posted

September 7, 2015

Last Updated

May 7, 2018

Sponsor

Chun Lim

1. Study Identification

Unique Protocol Identification Number

NCT02695927

Brief Title

Rehabilitation Glasses for the Treatment of Hemispatial Neglect

Official Title

Rehabilitation Glasses for the Treatment of Hemispatial Neglect

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 26, 2018 (Actual)

Study Completion Date

March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chun Lim

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemispatial Neglect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.

Masking

Participant

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic

Arm Type

Experimental

Arm Description

Crossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect

Arm Title

Acute

Arm Type

Experimental

Arm Description

Randomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect

Arm Title

Optimization

Arm Type

Experimental

Arm Description

Study to identify optimal operating parameters of computer rehabilitation glasses

Arm Title

Duration

Arm Type

Active Comparator

Arm Description

Study to determine duration of effect of computer rehabilitation glasses

Intervention Type

Device

Intervention Name(s)

Computer rehabilitation glasses

Primary Outcome Measure Information:

Title

Improvement of patient's hemispatial neglect scores

Description

Behavioral Inattention Test

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

34196963

Citation

Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

Results Reference

derived

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Rehabilitation Glasses for the Treatment of Hemispatial Neglect

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