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NCT05085210 · ClinicalTrials.gov registry record · NA
Improving Visual Field Deficits With Noninvasive Brain Stimulation
A NA study of Stroke and Visual Impairment, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05085210 is a NA study of Stroke and Visual Impairment that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 24 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05085210, a NA study of Stroke and Visual Impairment, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Sham stimulation
- DEVICE transcranial random noise stimulation (tRNS)
- BEHAVIORAL Computer Based Visual Training
- BEHAVIORAL Virtual Reality Based Visual Training
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05085210
The ClinicalTrials.gov registry entry for NCT05085210 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Stroke appearing as the primary indexed condition, and to 4 interventions - of which Sham stimulation is the first listed.
NCT05085210 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05085210 about?
NCT05085210 is a clinical study titled "Improving Visual Field Deficits With Noninvasive Brain Stimulation". 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...
What is the current status of trial NCT05085210?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2022-01-25. Estimated completion is 2026-06.
What conditions does trial NCT05085210 study?
This clinical trial studies the following conditions: Stroke, Visual Impairment, Visual Field Defect, Peripheral, Quadrantanopia, Cortical Blindness.
What interventions are being tested in trial NCT05085210?
The interventions under investigation include: Sham stimulation (DEVICE), transcranial random noise stimulation (tRNS) (DEVICE), Computer Based Visual Training (BEHAVIORAL), Virtual Reality Based Visual Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT05085210?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05085210 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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