Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia (OPTO)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Anne-Gaëlle Grosmaire
- Telefonnummer: +33164715200
- E-Mail: ag.grosmaire@les-trois-soleils.fr
Studieren Sie die Kontaktsicherung
- Name: Clotilde Guillerot
- E-Mail: c.guillerot@les-trois-soleils.fr
Studienorte
-
-
Île-de-France Region
-
Boissise-le-Roi, Île-de-France Region, Frankreich, 77310
- Clinique Les Trois Soleils
-
Kontakt:
- Catherine Maulny
- Telefonnummer: +33164718000
- E-Mail: c.maulny@les-trois-soleils.fr
-
Hauptermittler:
- Christophe Duret
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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. |
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. |
|
Sonstiges: 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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in reading speed on paper
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in reading accuracy on paper
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Christophe Duret, Clinique Les Trois Soleils, Boissise-le-Roi, France
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Goodwin D. Homonymous hemianopia: challenges and solutions. Clin Ophthalmol. 2014 Sep 22;8:1919-27. doi: 10.2147/OPTH.S59452. eCollection 2014.
- Schuett S, Heywood CA, Kentridge RW, Zihl J. Rehabilitation of hemianopic dyslexia: are words necessary for re-learning oculomotor control? Brain. 2008 Dec;131(Pt 12):3156-68. doi: 10.1093/brain/awn285. Epub 2008 Nov 3.
- Zihl J. Eye movement patterns in hemianopic dyslexia. Brain. 1995 Aug;118 ( Pt 4):891-912. doi: 10.1093/brain/118.4.891.
- Spitzyna GA, Wise RJ, McDonald SA, Plant GT, Kidd D, Crewes H, Leff AP. Optokinetic therapy improves text reading in patients with hemianopic alexia: a controlled trial. Neurology. 2007 May 29;68(22):1922-30. doi: 10.1212/01.wnl.0000264002.30134.2a.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Augenkrankheiten
- Sehstörungen
- Empfindungsstörungen
- Blindheit
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Streicheln
- Hemianopsie
Andere Studien-ID-Nummern
- 2026-A00195-46
- 26.02108.000598 (Andere Kennung: SI (CPP))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .