Rehabilitation Glasses for the Treatment of Hemispatial Neglect

NCT ID: NCT02695927

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2018-03-26

Brief Summary

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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

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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.

Conditions

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Hemispatial Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chronic

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

Group Type EXPERIMENTAL

Computer rehabilitation glasses

Intervention Type DEVICE

Acute

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

Group Type EXPERIMENTAL

Computer rehabilitation glasses

Intervention Type DEVICE

Optimization

Study to identify optimal operating parameters of computer rehabilitation glasses

Group Type EXPERIMENTAL

Computer rehabilitation glasses

Intervention Type DEVICE

Duration

Study to determine duration of effect of computer rehabilitation glasses

Group Type ACTIVE_COMPARATOR

Computer rehabilitation glasses

Intervention Type DEVICE

Interventions

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Computer rehabilitation glasses

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chun Lim

OTHER

Sponsor Role lead

Responsible Party

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Chun Lim

Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34196963 (View on PubMed)

Other Identifiers

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2009P000297

Identifier Type: -

Identifier Source: org_study_id

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