NCT02482350

Brief Summary

Hemianopia refers to compromised vision in one half of the visual field, in either one or both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually caused by stroke or head injury. In order to read, participants have to move their eyes along a line of text three to four times per second. Such eye movements are called saccades. One makes use of peripheral visual information to the right (if reading from left to right, e.g., in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA patients are deprived of much of this information. Patients with HA require far more saccades, which slows their reading significantly and often prevents them from reading efficiently for work or pleasure. It follows that the reading ability of those who read left-to-right would be compromised more by right-sided HA, and in those who read right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of left-sided HA following stroke, in Arabic readers. An online treatment package has been developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment resources exist for the condition in right-to-left readers. The aim is to develop novel Arabic reading tests and rehabilitation material. The current project proposes to 1) translate this package into Arabic, 2) develop new Arabic reading test materials and 3) collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to develop an effective, novel, and empirically supported reading treatment package for Arabic readers with HA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable stroke

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

June 15, 2015

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement of reading speed

    Average total reading time will be calculated in words per minute (wpm) using descriptive statistics in IBM SPSS.

    1 month

Secondary Outcomes (3)

  • Patients will report improvement in static text reading (newspapers, books, letters, etc.) as a function of quality activity of daily living.

    2 months

  • Decrease in the number of fixations

    1 month

  • Decrease in average fixation durations

    1 month

Study Arms (1)

Reading Training

EXPERIMENTAL

A 3-months study design. There will be three distinct phases: base-line testing, reading training, and follow-up testing. T1-T7 indicate the 7 time-points at which we assess the following: reading speeds (word-per-minute), visual field test, visual search test, and Activities of Daily Living rating scale (T1: Day 1, Initial assessments; T2: Day 30, Pre-training assessments; T3: Day 60, During Reading Training (RT) after 5-hours; T4: During RT after 10-hours; T5: During RT after 15-hours; T6: During RT after 20-hour; T7: Day 90, Post-training assessments). Arabic reading patients with left-sided HA will receive app-delivered reading training in a single subject control based design for 1 month.

Behavioral: Reading Training

Interventions

Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text.

Reading Training

Eligibility Criteria

Age26 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must:
  • Have a right-sided hemispheric stroke, tumor or head injury
  • Demonstrate a fixed left visual field homonymous deficit as defined by missing one or more stimuli on the automated visual field test developed for the application
  • Have a baseline text reading speed of more than 40 words per minute
  • Have been Arabic readers premorbidly

You may not qualify if:

  • Patients presenting:
  • impaired speech production, speech comprehension or writing (to rule out those with central alexia)
  • a premorbid history of neurological or psychiatric illness
  • a baseline text reading speed of less than 40 words per minute (to exclude patients with pure alexia) will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Wellington Hospital

London, NW8 9LE, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jennifer T Crinion, PhD

    Institute of Cognitive Neuroscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 26, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations