Neurofeedback-based Visual Restoration Therapy

NCT ID: NCT07237412

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2028-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Visual Field Defect Homonymous Bilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active phase

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.

Group Type ACTIVE_COMPARATOR

neurofeedback

Intervention Type 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.

control phase

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.

Group Type SHAM_COMPARATOR

neurofeedback

Intervention Type 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.

Interventions

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neurofeedback

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adrian Guggisberg

OTHER

Sponsor Role lead

Responsible Party

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Adrian Guggisberg

Full Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Inselspital

Bern, Canton of Bern, Switzerland

Site Status RECRUITING

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Switzerland

Central Contacts

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Adrian Guggisberg, MD

Role: CONTACT

+41795537291

Facility Contacts

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Despina Zlatkova

Role: primary

+41764138289

Adrian Guggisberg, MD

Role: primary

0795537291

References

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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.

Reference Type BACKGROUND
PMID: 21763527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30112275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33158966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34284245 (View on PubMed)

Other Identifiers

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2025-00765

Identifier Type: -

Identifier Source: org_study_id

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