Improving Visual Field Deficits With Noninvasive Brain Stimulation

Summary

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

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

Interventions

DEVICE

transcranial random noise stimulation (tRNS)

noninvasive current stimulation for 20 - 30 minutes stimulation on visual cortex (electrodes on surface of scalp, positioned O1 / O2 on EEG cap). 1mA max amplitude noise stimulation, frequencies from 100 Hz - 640 Hz.

BEHAVIORAL

Computer Based Visual Training

Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center of screen during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

DEVICE

Sham stimulation

20-30 minutes sham stimulation on visual cortex. Participants receive identical setup to real stimulation. The device provides a short ramp on period to simulate the feeling of real stimulation at the start but no current is delivered otherwise.

BEHAVIORAL

Virtual Reality Based Visual Training

• Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center point within the VR headset during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Lorella Battelli, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-25

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations