NCT02695927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

9.1 years

First QC Date

September 7, 2015

Last Update Submit

May 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement of patient's hemispatial neglect scores

    Behavioral Inattention Test

    60 days

Study Arms (4)

Chronic

EXPERIMENTAL

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

Device: Computer rehabilitation glasses

Acute

EXPERIMENTAL

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

Device: Computer rehabilitation glasses

Optimization

EXPERIMENTAL

Study to identify optimal operating parameters of computer rehabilitation glasses

Device: Computer rehabilitation glasses

Duration

ACTIVE COMPARATOR

Study to determine duration of effect of computer rehabilitation glasses

Device: Computer rehabilitation glasses

Interventions

AcuteChronicDurationOptimization

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 7, 2015

First Posted

March 1, 2016

Study Start

March 1, 2009

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

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

Locations