Clinique Les Trois Soleils
Boissise-le-Roi, Île-de-France Region, 77310, France
NCT Number: NCT07830745
The goal of this clinical trial is to investigate whether optokinetic stimulation delivered without a reading task can improve reading performance in adults with post-stroke hemianopic alexia. The main question it aims to answer is: does optokinetic stimulation without a reading task improve reading speed more than optokinetic stimulation with a reading task? Optokinetic stimlation with a reading task is considered the standard rehabilitation. These two conditions will be administered according to a randomized crossover design to determine wether the presence or absence of a reading task influences reading outcomes.
Participants will
* receive 4 weeks of optokinetic stimulation without a reading task and 4 weeks of optokinétic stimulation with a reading task, with the order of these two interventions determined by randomization, * undergo assesments of reading performance, oculomotor behavior, visual field and rehabilitation tolerability before and after each intervention period, * undergo a follow-up assesment 1 month after completion of the interventions.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Boissise-le-Roi, Île-de-France Region, 77310, France
Stroke can cause a visual field defect known as homonymous hemianopia (HH). When this visual field loss involves the macula, the central area of vision, it may result in reading difficulties known as hemianopic alexia (HA).
The literature reports improved reading performance in these patients after repeated induction of horizontal optokinetic nystagmus (i.e., an oculomotor reflex consisting of horizontal saccades). To induce this nystagmus, previous studies have used a reading task involving text scrolling from right to left.
However, this type of exercise, which relies on reading, is cognitively demanding and may lead to frustration due to reading difficulties, fatigue, and reduced motivation and potentially the impact of rehabilitation. Therefore, the use of a non-reading task could help overcome these limitations.
The present study aims to compare the efficacy of optokinetic stimulation with reading to optokinetic stimulation without reading in patients with HA.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants are exposed to a horizontally moving optokinetic visual stimulus on a computer screen for 40 minutes per session. The task consists of viewing random sequences of letters scrolling from right to left. The sessions are spread out over 4 weeks, with 3 or 4 sessions per week, to achieve 10 hours (15 sessions) of optokinetic rehabilitation.
Participants are exposed to a horizontally moving optokinetic visual stimulus on a computer screen for 40 minutes per session. The task consists of reading aloud sentences scrolling from right to left. The sessions are spread out over 4 weeks, with 3 or 4 sessions per week, to achieve 10 hours (15 sessions) of optokinetic rehabilitation. The scrolling speed ranges from 85 to 275 words per minute, depending on the participant's reading accuracy.
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number of correctly read words per minute, assessed using the International Reading Speed Texts (IReST). For each participant, the change in reading speed will be calculated separately for the optokinetic rehabilitation condition with a reading task and for the optokinetic rehabilitation condition without a reading task. The within-participant changes obtained after each 4-week period will be pooled across the two randomized sequences and compared between conditions. A higher reading speed indicates better reading performance.
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number and type of errors (paralexias, omissions) assessed using the International Reading Speed Texts (IReST).
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number of correctly read words per minute, assessed using a screen-based reading task
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number and type of errors (paralexias, omissions), assessed during a screen-based reading task
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the score on the Hemianopia Reading Questionnaire (HRQ)
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number of fixations and in the mean fixation duration (in ms) during the screen-based reading task, assessed with an eyetracker
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in the number and in the mean amplitude of saccades (in degrees) during the screen-based reading task, assessed with an eyetracker
Time frame: Baseline and at the end of both rehabilitation: Week 0 and Week 8
Change of saccade amplitude and frequency during optokinetic stimulation
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in visual sensitivity (in dB) at each tested visual field location on automated static perimetry (Humphrey or Octopus)
Time frame: Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in number of correctly detected targets and mean reaction time (in ms) at each tested visual field location on screen-based perimetry
Time frame: Before and after each rehabilitation session
Score of fatigue, stress, and mood induced by the treatment, self-assessed using a numbered visual analogue scale
Time frame: End of each 4-week rehabilitation period: Week 4 and Week 8
Score obtained on the Situational Motivation Scale
Contact information is provided by the study sponsor or research team.
Anne-Gaëlle Grosmaire
CONTACT
Clotilde Guillerot
CONTACT
Clinique Les Trois Soleils
Other
Acronym: OPTO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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