Visual Plasticity Following Brain Lesions (VIBRANT)

Georgetown University

Status: Enrolling

Conditions: Traumatic Brain Injury; Stroke; Brain Tumor; Visual Field Defect, Peripheral; Hemianopia; Visual Field Defect; Cortical Blindness; Quadrantanopia

Treatments: Behavioral: Perceptual learning-based training; Device: Sham Stimulation; Device: transcranial random noise stimulation (tRNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07105358

STUDY00008292

Details and patient eligibility

About

The VIBRANT (Vision Improvement through Behavioral Rehabilitation And Neuroplasticity Training) study is a prospective, double-blind, crossover design (within-subject) in participants with homonymous hemianopia-a type of visual field loss resulting from damage to the post-chiasmatic visual pathways. It aims to investigate whether transcranial random noise stimulation (tRNS) combined with perceptual learning-based training has potential for improving visual impairments.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

A. Stroke, brain tumor, or traumatic brain injury patients

Inclusion Criteria:

1. At least 18 years of age.
2. Capable of providing informed consent and complying with study procedures.
3. Unilateral or bilateral focal brain damage causing loss of vision.
4. At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.

Exclusion Criteria:

1. Severe CNS diseases or disorders unrelated to the focal lesion, which could interfere with study results.
2. Severe mental health challenges that could interfere with study results, or current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-5.
3. Vision loss resulting from ocular disease or disorder.

B. Healthy volunteers (age-matched controls):

Inclusion Criteria:

1. At least 18 years of age.
2. Capable of providing informed consent and complying with study procedures.

Exclusion Criteria:

1. Any CNS diseases or psychiatric disorders (e.g., epilepsy, schizophrenia) that would interfere with study results.
2. Previous head injury.
3. Present or past (within past 6 months) drug or alcohol abuse or addiction based on DSM-5.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

tRNS with perceptual learning-based training

Experimental group

Description:

Each 2-day session consists of up to three 18-minute transcranial random noise stimulation (tRNS) paired with perceptual learning-based training.

Treatment:

Device: transcranial random noise stimulation (tRNS)

Behavioral: Perceptual learning-based training

Sham with perceptual learning-based training

Sham Comparator group

Description:

Each 2-day session consists of up to three 18-minute sham stimulation paired with perceptual learning-based training.

Treatment:

Device: Sham Stimulation

Behavioral: Perceptual learning-based training