Improving Visual Field Deficits With Noninvasive Brain Stimulation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05085210
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • transcranial random noise stimulation (tRNS) — DEVICE
    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.
  • Computer Based Visual Training — BEHAVIORAL
    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.
  • Sham stimulation — DEVICE
    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.
  • Virtual Reality Based Visual Training — BEHAVIORAL
    • 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.

Study Details

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.

Key Dates

Start date
Jan 25, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Computer Visual Training with Noninvasive Brain Stimulation
    10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer
  • Experimental: Visual Training with Sham Stimulation
    10 daily (Monday-Friday) 20-30 minute sessions of sham stimulation with visual training on the computer
  • Experimental: Noninvasive Brain Stimulation without visual training
    10 daily (Monday-Friday) 20-30 minute sessions of tRNS alone
  • Sham Comparator: Sham Stimulation without visual training
    Placebo control. Simulation of tRNS without receiving any actual stimulation
  • Experimental: VR Visual Training with Noninvasive Brain Stimulation
    10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer

Primary Outcome Measure

Visual Motion Discrimination Change [ Time Frame: After 10 days training/stimulation and after 6 months training/stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Alisha Roby, MBA
[email protected]
(617) 667-0228
Lorella Battelli, PhD (PRINCIPAL_INVESTIGATOR)
Sabrina Pires, BS (SUB_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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