Neurofeedback-based Visual Restoration Therapy

NCT07237412 | Recruiting

• 1 other identifier: 2025-00765
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Visual field defects are a common consequence of acquired brain injuries and affect people of all ages. These vision problems make everyday life more difficult-for example, when reading, driving, or moving around safely. However, there is currently no effective therapy to improve visual field defects. Previous training methods have focused on maximizing brain activity during a task. However, new findings show that the best performance is achieved when the brain is already in a state of high communication before the task. Our research shows that people can learn to increase communication between brain regions through neurofeedback. Studies have shown that neurofeedback can help people after a stroke: it improves the coordination of brain areas that are important for movement, thereby helping to increase mobility. Building on these findings, this study investigates whether EEG neurofeedback can support the visual centers in the brain to improve vision in patients with chronic visual field defects. The main objective of the study is to evaluate the effectiveness of neurofeedback in improving visual field defects. More specifically, the investigators are investigating the development of visual ability (expansion of the visual field, contrast sensitivity).

Conditions

Visual Field Defect Homonymous Bilateral

Keywords

stroke; neurofeedback; network; EEG

Outcome Measures

Primary Outcomes (1)

• Visual field

  This will be evaluated using the Haag-Streit Octopus 900 perimetry device (Haag-Streit AG, Köniz, Switzerland). The device features advanced gaze-tracking capabilities that effectively control compensatory eye movements, ensuring accurate measurement of visual field improvements. The Central 30-2 protocol will be followed. The primary outcome will be the change in the Mean Deviation (MD) score in detection threshold (in dB) from baseline to the end of the intervention period within the target area of affected visual field. The MD score represents the overall deviation of the patient's visual field from age-matched normative data, with more negative values indicating greater visual field loss.

  Change from enrollment to post-test at 3 weeks and follow up at 7 weeks (repeated-measures ANOVA)

Secondary Outcomes (3)

• Changes in alpha-band functional connecticity

  Change from entrollment to the end of treatment at 3 weeks.

• Questionnaire on daily-life impact of the visual impairment

  Change from enrollment to treatment end at 3 weeks

• Reading speed

  Change from enrollment to treatment end at 3 weeks and follow up at 7 weeks (repeated-measures ANOVA).

Other Outcomes (3)

• Test of Attentional Performance (TAP) Visual Scanning

  Change from enrollment to treatment end at 3 weeks

• Test of Attentional Performance (TAP) Sustained Attention

  Change from enrollment to treatment end at 3 weeks.

• Test of Attentional Performance (TAP) Visual field and Neglect test

  Change from enrollment to treatment at 3 weeks.

Study Arms (2)

Active phase

ACTIVE COMPARATOR

During the active phase, patients will receive real-time audio feedback on spontaneous alpha-band functional connectivity between ipsilesional associative visual areas and the rest of the brain. This will allow them to learn to improve their pathological brain interactions. The neurofeedback training will last about 40 minutes, with frequent breaks. It will be followed by visual stimulation of the affected visual field according to recommendations for inducing steady-state visual evoked potentials.

Procedure: neurofeedback

control phase

SHAM COMPARATOR

The control phase is structured identically to the active period, except that the acoustic neurofeedback is synthetically generated and not linked to the subject's actual functional connectivity, while still resembling its dynamic characteristics to ensure effective blinding. The training will last about 40 minutes, with frequent breaks. The training will be followed by visual stimulation of the affected visual field, just as in the active condition.

Procedure: neurofeedback

Interventions

neurofeedback PROCEDURE

The proposed neurofeedback approach relies on high-density electroencephalography (EEG) combined with advanced source localization algorithms. Data will be analyzed in real-time and simultaneously recorded for offline analysis. During each update, a data segment will be filtered between 1 and 20 Hz. The beamformer, computed at the beginning of the session, will be used to project the signal to the gray-matter voxels. The investigators will compute the alpha-band absolute imaginary coherence between a visual target area and the rest of the brain as index of functional connectivity. Global functional connectivity in the alpha band (8-13 Hz) between the voxels in the target region and the rest of the brain will be calculated.

Active phase; control phase

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic, stable HVFD (homologous lateral quadranopsia or hemianopsia)
• months or more after stroke
• Age range 50-70
• Ability to provide informed consent

You may not qualify if:

• Inability to concentrate for long treatment sessions
• Eye disease with impact on visual field or acuity
• Presence of non-MRI safe metal in the body
• New stroke during study period
• Hemispatial neglect

Sponsors & Collaborators

• Adrian Guggisberg: lead

Study Sites (2)

Inselspital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1202, Switzerland

NOT YET RECRUITING

Related Publications (4)

• Sabel BA, Henrich-Noack P, Fedorov A, Gall C. Vision restoration after brain and retina damage: the "residual vision activation theory". Prog Brain Res. 2011;192:199-262. doi: 10.1016/B978-0-444-53355-5.00013-0.

  PMID: 21763527 BACKGROUND

• Mottaz A, Corbet T, Doganci N, Magnin C, Nicolo P, Schnider A, Guggisberg AG. Modulating functional connectivity after stroke with neurofeedback: Effect on motor deficits in a controlled cross-over study. Neuroimage Clin. 2018 Jul 30;20:336-346. doi: 10.1016/j.nicl.2018.07.029. eCollection 2018.

  PMID: 30112275 BACKGROUND

• Allaman L, Mottaz A, Kleinschmidt A, Guggisberg AG. Spontaneous Network Coupling Enables Efficient Task Performance without Local Task-Induced Activations. J Neurosci. 2020 Dec 9;40(50):9663-9675. doi: 10.1523/JNEUROSCI.1166-20.2020. Epub 2020 Nov 6.

  PMID: 33158966 BACKGROUND

• Allaman L, Mottaz A, Guggisberg AG. Disrupted resting-state EEG alpha-band interactions as a novel marker for the severity of visual field deficits after brain lesion. Clin Neurophysiol. 2021 Sep;132(9):2101-2109. doi: 10.1016/j.clinph.2021.05.029. Epub 2021 Jun 28.

  PMID: 34284245 BACKGROUND

MeSH Terms

Conditions

Hemianopsia; Stroke

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Adrian Guggisberg, MD

CONTACT

+41795537291; adrian.guggisberg@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CH (2)