Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05085210

Improving Visual Field Deficits With Noninvasive Brain Stimulation

Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-04

24

Participants Needed

1

Research Sites

226 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.

CONDITIONS

Official Title

Improving Visual Field Deficits With Noninvasive Brain Stimulation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Presence of some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere as shown by MRI or CT scans
  • First ever ischemic or hemorrhagic stroke with damage to primary visual cortex causing partial vision loss
  • Ischemic stroke patients can be subacute (within 6 months) or chronic (more than 6 months)
  • Hemorrhagic stroke patients must be chronic (more than 6 months)
  • Demonstrated visual perception deficit in parts of visual field measured by visual perimetry
  • Imaging shows stroke primarily affects the visual cortex
  • Willing and able to follow study procedures
Not Eligible

You will not qualify if you...

  • No damage to primary visual cortex
  • Visual cortex damage from a subsequent stroke (not the primary stroke)
  • Total blindness in both left and right visual fields
  • Unable to fixate visual targets or perform visual training exercises as required
  • Complete loss of reading ability
  • History of neurological disorders other than stroke (e.g., epilepsy, multiple sclerosis, brain lesions)
  • Poorly controlled migraines or chronic migraine medication use
  • History of seizures, epilepsy, abnormal EEG, or immediate family history of epilepsy (except single benign seizure)
  • History of fainting spells that may be seizures
  • History of major depression, bipolar disorder, psychotic or major psychiatric conditions
  • Presence of one-sided attentional neglect determined by neuropsychological tests
  • Contraindications to receiving transcranial random noise stimulation (tRNS)
  • Uncontrolled or unstable medical illnesses that risk emergencies during seizures
  • Substance abuse or dependence in past 6 months
  • Pregnant or breastfeeding women
  • Hair style or head dress that prevents electrode contact (e.g., thick braids, wig)
  • For virtual reality group only: contraindication to VR or implanted medical devices like pacemaker or nerve stimulators
  • Any participant deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

L

Lorella Battelli, PhD

CONTACT

M

Meghna Uzgare, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

5

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