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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 18 years of age or older.

• 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.

• 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)

• Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry.

• Imaging evidence that the stroke is primarily affecting the visual cortex.

• Willing and able to participate in the study protocol and to comply with study procedures.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Lorella Battelli, PhD
lbattell@bidmc.harvard.edu
617-667-0326
Backup
Meghna Uzgare, BS
muzgare@bidmc.harvard.edu
(617) 667-0362
Time Frame
Start Date: 2022-01-25
Estimated Completion Date: 2026-06
Participants
Target number of participants: 24
Treatments
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
Authors
Thomas Pandolfi
Related Therapeutic Areas
Sponsors
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov