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Randomized Controlled Trial
. 2020 May 11;9(6):6.
doi: 10.1167/tvst.9.6.6. eCollection 2020 May.

Biofeedback Rehabilitation and Visual Cortex Response in Stargardt's Disease: A Randomized Controlled Trial

Paolo Melillo  1 , Anna Prinster  2 , Valentina Di Iorio  1 , Gaia Olivo  3 , Francesco Maria D'Alterio  1 , Sirio Cocozza  3 , Mario Quarantelli  2 , Francesco Testa  1 , Arturo Brunetti  3 , Francesca Simonelli  1
Affiliations
Randomized Controlled Trial

Biofeedback Rehabilitation and Visual Cortex Response in Stargardt's Disease: A Randomized Controlled Trial

Paolo Melillo et al. Transl Vis Sci Technol. .

Abstract

Purpose: to evaluate the effect of biofeedback (BF) rehabilitation on the visual function and on the activity of primary visual cortex (PVC) in patients with Stargardt's disease owing to mutations in the ABCA4 gene (STGD1).

Methods: This was a single-center, controlled, randomized study. Twenty-four patients with STGD1 were randomized into two groups: a treatment group (TG) undergoing BF rehabilitation and a control group (CG). Treatment with BF consisted of a 10-minute session per eye performed weekly for 12 weeks. The subjects underwent a baseline and 3-month follow-up visits, including best-corrected visual acuity (BCVA), reading test, microperimetry, and functional magnetic resonance imaging (fMRI). The fMRI studies were acquired sequentially using a passive viewing condition and an active reading task. The primary outcomes were the change in the fMRI activation of primary visual cortex and the change in reading ability.

Results: After treatment, the patients in the TG were able to read smaller characters (P = 0.002) with a greater reading speed (P = 0.014) compared with patients in the CG. The fMRI studies showed a significant effect (P < 0.001) of BF on primary visual cortex activation in the TG compared with the CG. Finally, we observed significant (P < 0.05) improvements of best-corrected visual acuity, macular sensitivity, and fixation stability parameters in the TG compared with the CG.

Conclusions: Our study showed that visual rehabilitation using BF improved the usage of residual visual function in patients with STGD1.

Translational relevance: Our findings show that the BF treatment compared with no treatment at all resulted in benefits. The specificity of the treatment could be examined to determine whether BF can be included in clinical practice.

Keywords: Stargardt disease; biofeedback; visual cortex; visual rehabilitation.

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Conflict of interest statement

Disclosure: P. Melillo, Sanofi R&D (R), Shire (R); A. Prinster, None; V. Di Iorio, Shire (R); G. Olivo, None; F.M. D'Alterio, None; S. Cocozza, Sanofi (R), Amicus (R); M. Quarantelli, None; F. Testa, Sanofi R&D (R), Shire (R); A. Brunetti, None; F. Simonelli, Sanofi R&D (R), Shire (R), Spark Therapeutics (R)

Figures

Figure 1.
Figure 1.
Flow diagram of the study.
Figure 2.
Figure 2.
Change in visual reading test parameters: best corrected visual acuity (a), reading speed (b), minimum print size (c).
Figure 3.
Figure 3.
Changes in microperimetric parameters: macular sensitivity (a); fixation stability within 2° (b); fixation stability within 4° (c); bivariate contour ellipse area 68.2% (d); 95.4% (e); and 99.6% (f).
See this image and copyright information in PMC

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