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Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia (OPTO)

15 septembre 2026 mis à jour par: Clinique Les Trois Soleils

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
    • Île-de-France Region
      • Boissise-le-Roi, Île-de-France Region, France, 77310
        • Clinique Les Trois Soleils
        • Contact:
        • Chercheur principal:
          • Christophe Duret

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Time since lesion > 1 month
  • Diagnosis of homonymous hemianopia post-stroke without macular sparing
  • Reading complaint and/or reading impairment
  • Proficiency in reading French
  • Agreed to give informed consent
  • Afiliated with national health insurance

Exclusion Criteria:

  • History of neurological or psychiatric disorders
  • Visual impairment of peripheral origin (i.e., related to damage to the structures of the eye or the optic nerve)
  • Uncorrected visual acuity deficit
  • Reading disorder prior to the stroke (dyslexia)
  • Instability of reading impairment
  • Instability of homonymous hemianopia
  • Major cognitive that would limit the ability of the patient to participate in the study (unilateral spatial neglect, simultanagnosia, comprehension disorder, oral expression disorder)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Group A

Patients receive 15 sessions of optokinetic rehabilitation with a reading task, followed by 15 sessions of optokinetic rehabilitation without an associated reading task.

The optokinetic rehabilitation sessions with reading are considered the standard of care, while optokinetic rehabilitation without an associated reading task is the experimental condition. Each patient undergoes both conditions sequentially and serves as their own control.
Autre: Optokinetic stimulation without reading task

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.

Autre: Optokinetic stimulation with reading task

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.
Autre: Group B

Patients receive 15 sessions of optokinetic rehabilitation without an associated reading task, followed by 15 sessions of optokinetic rehabilitation with a reading task.

The optokinetic rehabilitation sessions with reading are considered the standard of care, while optokinetic rehabilitation without an associated reading task is the experimental condition. Each patient undergoes both conditions sequentially and serves as their own control.
Autre: Optokinetic stimulation without reading task

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.

Autre: Optokinetic stimulation with reading task

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in reading speed on paper
Délai: 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.
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in reading accuracy on paper
Délai: 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).
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in reading speed on screen
Délai: 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
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in reading accuracy on screen
Délai: 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
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in subjective reading abilities
Délai: 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)
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in ocular fixations during reading
Délai: 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
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in ocular saccades during reading
Délai: 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
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in optokinetic nystagmus
Délai: Baseline and at the end of both rehabilitation: Week 0 and Week 8

Change of saccade amplitude and frequency during optokinetic stimulation
Baseline and at the end of both rehabilitation: Week 0 and Week 8
Change in visual detection during standard perimetry
Délai: 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)
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Change in visual detection during screen-based perimetry
Délai: 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
Baseline and end of each 4-week rehabilitation period: Week 0, Week 4, and Week 8
Tolerability of rehabilitation
Délai: Before and after each rehabilitation session

Score of fatigue, stress, and mood induced by the treatment, self-assessed using a numbered visual analogue scale
Before and after each rehabilitation session
Motivation for rehabilitation
Délai: End of each 4-week rehabilitation period: Week 4 and Week 8

Score obtained on the Situational Motivation Scale
End of each 4-week rehabilitation period: Week 4 and Week 8

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Clinique Les Trois Soleils

Collaborateurs

Laboratoire Mémoire Cerveau et Cognition, Boulogne-Billancourt, France

Les enquêteurs

  • Chercheur principal: Christophe Duret, Clinique Les Trois Soleils, Boissise-le-Roi, France

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

15 septembre 2026

Première soumission répondant aux critères de contrôle qualité

15 septembre 2026

Première publication (Réel)

21 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-A00195-46
  • 26.02108.000598 (Autre identifiant: SI (CPP))

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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