Improving vision in patients with visual field deficits using brain stimulation

Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery

This study is testing if a new brain stimulation technique combined with visual training can help people who have lost part of their vision after a stroke see better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05085210 on ClinicalTrials.gov

What this trial studies

This pilot interventional study aims to enhance visual abilities in participants suffering from visual field deficits due to cortical lesions, particularly following a stroke. The approach involves using noninvasive brain stimulation techniques, specifically transcranial random noise stimulation (tRNS), combined with visual training exercises. Participants will undergo assessments using traditional visual perimetry and virtual reality-based visual training to measure improvements in their visual fields. The study seeks to refine rehabilitation protocols that could lead to faster recovery of visual functions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced their first ischemic or hemorrhagic stroke affecting the primary visual cortex and have some intact visual cortical areas.

Not a fit: Patients who have not experienced a stroke or those with extensive damage to the visual cortex may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the visual capabilities of patients with visual field deficits, enhancing their quality of life.

How similar studies have performed: While there is limited data on the specific combination of techniques used in this study, noninvasive brain stimulation has shown promise in other studies for improving visual function.

Eligibility criteria

Inclusion Criteria:

1. 18 years of age or older.
2. Presence of some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist.
3. First ever ischemic or hemorrhagic stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field.

   * Ischemic stroke patients will be either subacute (within 6 months of their stroke) or chronic (more than 6 months)
   * Hemorrhagic stroke patients will be chronic only (greater than 6 months)
4. Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry.
5. Imaging evidence that the stroke is primarily affecting the visual cortex.
6. Willing and able to participate in the study protocol and to comply with study procedures.

Exclusion Criteria:

1. No evidence of damage to the primary visual cortex.
2. Visual cortex damage as a result of a subsequent stroke (not primary).
3. Total cortical blindness, covering both left and right visual fields.
4. Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed.
5. Complete loss of reading abilities.
6. Current or prior history of any neurological disorder other than stroke, such as epilepsy, a progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions other than the qualifying stroke lesion.
7. Current history of poorly controlled migraines including chronic medication for migraine prevention.
8. History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or immediate (1st degree relative) family history of epilepsy; with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator.
9. History of fainting spells of unknown or undetermined etiology that might constitute seizures.
10. Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
11. Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks.
12. Contraindication for receiving tRNS.
13. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
14. Any complex, uncontrolled/unstable or terminal medical illness.
15. Substance abuse or dependence within the past six months.
16. Medications will be reviewed by the responsible MD (Drs. Sandeep Kumar or Dan Press) and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS active drugs.
17. All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study.
18. Subjects who, in the investigator's opinion, might not be suitable for the study.
19. A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig).
20. Additional criteria for Group 1b only: Contraindication for using VR technology, specifically an implanted medical device such as a pacemaker, implanted defibrillator, deep brain or vagal nerve stimulator. Participants with a history of seizures are already excluded per the above criteria.

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Lorella Battelli, PhD — Beth Israel Deaconess Medical Center
• Study coordinator: Lorella Battelli, PhD

Conditions: Visual Field Defect, Peripheral, Stroke, Visual Impairment, Hemianopsia, Quadrantanopia, Cortical Blindness, Visual Field Defect Homonymous Bilateral, Occipital Lobe Infarct