Improving Visual Field Deficits With Noninvasive Brain Stimulation (NCT05085210) | Clinical Trial Compass
RecruitingNot Applicable
Improving Visual Field Deficits With Noninvasive Brain Stimulation
United States24 participantsStarted 2022-01-25
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. No evidence of damage to the primary visual cortex.
✕. Visual cortex damage as a result of a subsequent stroke (not primary).
What they're measuring
1
Visual Motion Discrimination Change
Timeframe: After 10 days training/stimulation and after 6 months training/stimulation
. Total cortical blindness, covering both left and right visual fields.
✕. Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed.
✕. Complete loss of reading abilities.
✕. 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.
✕. Current history of poorly controlled migraines including chronic medication for migraine prevention.
✕. 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.