Biofeedback in Idiopathic Infantile Nystagmus Syndrome

NCT04142307 | Recruiting

• 1 other identifier: Biofeedback Low Vision
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Active eye movement control training, an old and still most prevalent intervention in low vision rehabilitation (LVR) was never used in nystagmus clinically. Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Laboratory studies in the literature highlighted positive benefits from using BT in nystagmus cases. The purpose of this study is to assess systematically the impact of BT in a series of cases with Infantile Idiopathic Nystagmus (IIN) and formulate guidelines for further use of this intervention in nystagmus cases in general.

Conditions

Low Vision in Children

Keywords

biofeedback; vision rehabilitation; nystagmus; paediatric

Outcome Measures

Primary Outcomes (2)

• Changes in Best Corrected Visual Acuity for Distance Vision across BT sessions and post BT

  Measured with the ETDRS charts at 4 m

  7 days from baseline (V2), 14 days (V3), 21 days (V4), 28 days (V5), 35 days (V6), and 118 days from baseline (V7)

• Changes in Fixation Stability (Bivariate contour ellipse area) across BT sessions and post BT

  Represents the area used for fixation on the retina in square degrees as given by the microperimeter

  7 days from baseline (V2), 14 days (V3), 21 days (V4), 28 days (V5), 35 days (V6), and 118 days from baseline (V7)

Secondary Outcomes (4)

• Changes in Contrast Sensitivity for near vision across BT sessions and post BT

  35 days from baseline (V6), and 118 days from baseline (V7)

• Changes in Stereopsis for near vision across BT and post BT

  35 days from baseline (V6), and 118 days from baseline (V7)

• Changes in Quality of Life Parental Questionnaire across BT and post BT

  35 days from baseline (V6), and 118 days from baseline (V7)

• Changes in Reading speed across BT sessions and post BT

  35 days from baseline (V6), and 118 days from baseline (V7)

Study Arms (2)

Group A (treatment)

ACTIVE COMPARATOR

Each session includes 20 minutes of training each with rest as needed. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. A fixation training target (FTT) will be selected by the trainer at a perceived better fixation point. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look in the direction of the FTT and listen simultaneously to the audio feedback. As performing this task, the participant will actively control the eye movements until the audio feedback becomes more frequent and then becomes a continuous sound pattern. This continuous sound will signalize to the patient that the FTT location was reached. Participants will be given take-home efficiency reading exercises.

Device: Biofeedback Training

Group B (control)

SHAM COMPARATOR

The simulated biofeedback training for Group B involves the following procedure: For four weeks, presentation of a C10-2 microperimetry program. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look at the FT and simultaneously to be aware of any flashing lights in the periphery of vision. As performing this task, the participant will actively control the eye movements and similar to computer games, the patient has to identify targets in the peripheral field of vision and respond by pressing a button. Participants will be given take-home efficiency reading exercises.

Device: Sham - simulated BT

Interventions

Biofeedback Training DEVICE

Microperimeter biofeedback training as described provides to the patient a variable frequency sound and a luminous stimulus that vary according to the eyes position, thus guides the oculomotor control and fixation stability accordingly.

Group A (treatment)

Sham - simulated BT DEVICE

The simulated biofeedback training for Group B involves the following: each session includes presentation of a C10-2 microperimetry program. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look at the FT and simultaneously to be aware of any flashing lights in the periphery of vision. As performing this task, the participant will actively control the eye movements and similar to computer games, the patient has to identify targets in the peripheral field of vision and respond by pressing a button.

Group B (control)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed as Infantile idiopathic nystagmus (IIN)
• Ability to follow the visual and auditory stimuli and training instructions

You may not qualify if:

• Ocular diseases not related to the nystagmus physiopathology
• Both eyes with media opacity that impairs microperimetry testing
• Peripheral nystagmus cases
• Other types of nystagmus than IIN
• Inability to perform during testing and training

Sponsors & Collaborators

• Monica Daibert Nido: lead

Study Sites (1)

CNIB

Toronto, Ontario, M4G 3E8, Canada

RECRUITING

Related Publications (16)

• Abadi RV, Bjerre A. Motor and sensory characteristics of infantile nystagmus. Br J Ophthalmol. 2002 Oct;86(10):1152-60. doi: 10.1136/bjo.86.10.1152.

  PMID: 12234898 BACKGROUND

• Rucker JC. Current Treatment of Nystagmus. Curr Treat Options Neurol. 2005 Jan;7(1):69-77. doi: 10.1007/s11940-005-0008-0.

  PMID: 15610709 BACKGROUND

• ANDERSON JR. Causes and treatment of congenital eccentric nystagmus. Br J Ophthalmol. 1953 May;37(5):267-81. doi: 10.1136/bjo.37.5.267. No abstract available.

  PMID: 13042022 BACKGROUND

• KESTENBAUM A. [New operation for nystagmus]. Bull Soc Ophtalmol Fr. 1953 Jun;6:599-602. No abstract available. Undetermined Language.

  PMID: 13115959 BACKGROUND

• Wang ZI MS, Dell'Osso LF , Ph.D. A Review of the Tenotomy Nystagmus Surgery: Origin, Mechanism, and General Efficacy. Neuro-Ophthalmology, 31:157-165, 2007 ISSN: 0165-8107 DOI: 10.1080/01658100701647704

  BACKGROUND

• Yaniglos SS, Stahl JS, Leigh RJ. Evaluation of current optical methods for treating the visual consequences of nystagmus. Ann N Y Acad Sci. 2002 Apr;956:598-600. doi: 10.1111/j.1749-6632.2002.tb02893.x. No abstract available.

  PMID: 11960878 BACKGROUND

• Lennerstrand G, Nordbo OA, Tian S, Eriksson-Derouet B, Ali T. Treatment of strabismus and nystagmus with botulinum toxin type A. An evaluation of effects and complications. Acta Ophthalmol Scand. 1998 Feb;76(1):27-7. doi: 10.1034/j.1600-0420.1998.760106.x.

  PMID: 9541431 BACKGROUND

• Buia C, Tiesinga P. Attentional modulation of firing rate and synchrony in a model cortical network. J Comput Neurosci. 2006 Jun;20(3):247-64. doi: 10.1007/s10827-006-6358-0. Epub 2006 Apr 22.

  PMID: 16683206 BACKGROUND

• Shtark MB, Kozlova LI, Bezmaternykh DD, Mel'nikov MY, Savelov AA, Sokhadze EM. Neuroimaging Study of Alpha and Beta EEG Biofeedback Effects on Neural Networks. Appl Psychophysiol Biofeedback. 2018 Jun;43(2):169-178. doi: 10.1007/s10484-018-9396-2.

  PMID: 29926265 BACKGROUND

• Markowitz SN, Reyes SV. Microperimetry and clinical practice: an evidence-based review. Can J Ophthalmol. 2013 Oct;48(5):350-7. doi: 10.1016/j.jcjo.2012.03.004. Epub 2012 Oct 23.

  PMID: 24093179 BACKGROUND

• Nido MD, Markowitz SN. Vision rehabilitation with biofeedback training. Can J Ophthalmol. 2018 Jun;53(3):e83-e84. doi: 10.1016/j.jcjo.2017.11.003. Epub 2017 Dec 21. No abstract available.

  PMID: 29784180 BACKGROUND

• Ciuffreda KJ, Goldrich SG, Neary C. Use of eye movement auditory biofeedback in the control of nystagmus. Am J Optom Physiol Opt. 1982 May;59(5):396-409. doi: 10.1097/00006324-198205000-00007.

  PMID: 7102798 BACKGROUND

• Grenga PL, Trabucco P, Meduri A, Fragiotta S, Vingolo EM. Microperimetric biofeedback in a patient with oculocutaneous albinism. Can J Ophthalmol. 2013 Oct;48(5):e105-7. doi: 10.1016/j.jcjo.2012.11.011. Epub 2013 Aug 29. No abstract available.

  PMID: 24093197 BACKGROUND

• Mezawa M, Ishikawa S, Ukai K. Changes in waveform of congenital nystagmus associated with biofeedback treatment. Br J Ophthalmol. 1990 Aug;74(8):472-6. doi: 10.1136/bjo.74.8.472.

  PMID: 2390522 BACKGROUND

• Daibert-Nido M, Patino B, Markowitz M, Markowitz SN. Rehabilitation with biofeedback training in age-related macular degeneration for improving distance vision. Can J Ophthalmol. 2019 Jun;54(3):328-334. doi: 10.1016/j.jcjo.2018.10.016. Epub 2019 Apr 2.

  PMID: 31109472 BACKGROUND

• Felius J, Stager DR Sr, Berry PM, Fawcett SL, Stager DR Jr, Salomao SR, Berezovsky A, Birch EE. Development of an instrument to assess vision-related quality of life in young children. Am J Ophthalmol. 2004 Sep;138(3):362-72. doi: 10.1016/j.ajo.2004.05.010.

  PMID: 15364217 BACKGROUND

MeSH Terms

Conditions

Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Samuel Markowitz, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Daibert-Nido, MD

CONTACT

4164819995; monica.nido@uhn.com

Samuel Markowitz, MD

CONTACT

4164819995

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective randomized controlled parallel group study ratio 1:1.

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 29, 2019
• Study Start: January 30, 2019
• Primary Completion: April 29, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)