Biofeedback for Nystagmus

Overseen By Samuel Markowitz, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Monica Daibert Nido

Disqualifiers: Ocular diseases, Media opacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with Infantile Idiopathic Nystagmus (IIN), a condition causing uncontrollable eye movements. The study tests biofeedback training (BT), which uses sounds and visual cues to help individuals learn to control their eye movements better. Participants will either undergo BT or a similar training without active feedback to compare outcomes. Individuals diagnosed with IIN who can follow simple visual and auditory instructions may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance eye movement control for those with IIN.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that biofeedback training is safe for nystagmus?

Research has shown that biofeedback training (BT) for nystagmus is generally safe. Studies on BT have not identified any safety issues, indicating it is well-tolerated. Past research demonstrated that BT can reduce the severity of nystagmus, an involuntary eye movement. Evidence also suggests it can improve balance and physical performance. While these findings are promising, anyone considering joining a trial should consult their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about biofeedback training for nystagmus because it offers a non-invasive, interactive approach to managing eye movements. Unlike standard treatments, which often rely on medications or surgeries, this method uses real-time audio feedback to help patients actively control their eye movements, potentially improving their vision and quality of life. The technique empowers patients to recognize and correct their eye positioning through a continuous sound pattern, making it a unique and promising option in the field of vision therapy.

What evidence suggests that biofeedback training is effective for nystagmus?

Research has shown that biofeedback training, which participants in this trial may receive, can help people with nystagmus, a condition causing uncontrollable eye movements. Studies have found that this training can improve physical abilities like balance and walking while reducing the severity of nystagmus symptoms. For example, in one case, the eye movement range decreased from 13.1 to 2.5 degrees. Patients reported improved vision both at a distance and when reading after this training. Overall, biofeedback training appears to be very effective in managing nystagmus. ^{1 2 4 6 7}

Who Is on the Research Team?

Samuel Markowitz, MD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Infantile Idiopathic Nystagmus (IIN) who can follow visual and auditory instructions. It's not suitable for those with eye conditions that affect testing, inability to perform during tests, or other types of nystagmus besides IIN.

Inclusion Criteria

You have been diagnosed with infantile idiopathic nystagmus (IIN).

Ability to follow the visual and auditory stimuli and training instructions

Exclusion Criteria

Both of your eyes have cloudy areas that make it hard to do a certain type of eye test.

You cannot complete the required tests and training.

You have eye conditions that are not related to nystagmus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including visual acuity, fixation stability, and quality of life estimates

1 day

1 visit (in-person)

Biofeedback Training

Participants undergo 4 biofeedback training sessions to improve oculomotor control and visual acuity

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in visual acuity and quality of life post-training

4 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback Training
• Sham - simulated BT

Trial Overview The study is evaluating Biofeedback Training (BT), a new technique in low vision rehabilitation aimed at improving eye movement control. Participants will be compared to a control group receiving simulated BT to measure the effectiveness of the real intervention.

How Is the Trial Designed?

Group I: Group A (treatment) Active Control 1 Intervention

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.

Group II: Group B (control) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Monica Daibert Nido

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04142307

Biofeedback in Idiopathic Infantile Nystagmus Syndrome Laboratory studies in the literature highlighted positive benefits from using BT in nystagmus cases.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524000831

An Innovative Approach for Nystagmus Rehabilitation Notable improvements in overall physical performance, especially in balance and gait, and a reduction in nystagmus severity were observed. Integrating ...

3. aboonline.org.br aboonline.org.br/details/6058/en-US/visual-outcomes-of-audio-luminous-biofeedback-training-for-a-child-with-idiopathic-nystagmus

Visual outcomes of audio-luminous biofeedback training ... The nystagmus amplitude estimate improved from 13.1 to 2.5 degrees (Figure 2). Subjectively, the patient reported an improvement in distance and reading at ...

4. withpower.com withpower.com/trial/phase-nystagmus-pathologic-2019-c5f3c

Biofeedback for Nystagmus Research shows that biofeedback training can help people with nystagmus (a condition causing involuntary eye movements) by reducing the severity of eye ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/1120672120940981

The efficacy of biofeedback visual rehabilitation therapy in ... Results: Twelve patients (mean age 8.9 years.) with INS completed the whole training session. All patients showed significant improvement in the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33567015/

Visual outcomes of audio-luminous biofeedback training ... Previous studies have shown that biofeedback training using electrical nystagmography can reduce nystagmus amplitude and increase foveation time. However, ...

7. researchgate.net researchgate.net/publication/349211386_Visual_outcomes_of_audio-luminous_biofeedback_training_for_a_child_with_idiopathic_nystagmus

Visual outcomes of audio-luminous biofeedback training ... Previous studies have shown that biofeedback training using electrical nystagmography can reduce nystagmus amplitude and increase foveation time ...