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NCT Number: NCT07105358

Visual Plasticity Following Brain Lesions

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.

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Key information

Conditions

Visual Field Defect Blindness Blindness, Cortical Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Neoplasms Brain Tumor Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Cortical Blindness Craniocerebral Trauma Eye Diseases Hemianopia Hemianopsia Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quadrantanopia Sensation Disorders Signs and Symptoms Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Vision Disorders Visual Field Defect, Peripheral Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location status: Recruiting

Location contact

Tina Liu, PhD

PRINCIPAL_INVESTIGATOR

Visual Perception and Plasticity Lab

CONTACT

[email protected]

202-784-9949

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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

Exclusion criteria

  • Severe CNS diseases or disorders unrelated to the focal lesion, which could interfere with study results.
  • 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.
  • Vision loss resulting from ocular disease or disorder.

B. Healthy volunteers (age-matched controls):

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

transcranial random noise stimulation (tRNS)

Device

Stimulation location: bilateral human middle temporal complex (hMT+). Stimulation parameters: 1 mA current intensity, with a frequency range of 101-640 Hz.

Sham stimulation

Device

Stimulation location: bilateral human middle temporal complex (hMT+). Stimulation parameters: Ramp up stimulation at 1mA with a frequency range of 101-640Hz for the first 30 seconds followed by no current for the remainder of the duration.

Perceptual learning-based training

Behavioral

A motion discrimination task, judging the global direction of moving dot stimuli with two different coherence levels.

Primary outcomes

  1. Change in Motion Discrimination Performance

    Time frame: Study visit 1 to 2 (within a week), and study visit 3 to 4 (within a week)

    Change in accuracy on a computerized motion direction discrimination task programmed in the lab. The task assesses participants' ability to discriminate the direction of the peripherally presented moving dots at two locations (one within the blind field and the other at a mirror-symmetric location in the intact visual field). Accuracy is defined as the proportion of correct responses out of the total number of trials completed.

Secondary outcomes

  1. Visual Field Change

    Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)

    Change in visual field function, assessed by perimetric mean deviation (PMD) measured using Humphrey perimetry. PMD is a global index representing the average deviation of visual field sensitivity compared to age-matched norms, measured in decibels (dB). More negative PMD values indicate greater visual field loss.

  2. Visual Perception Change

    Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)

    Change in visual perception in the following two task:

    • Face/Object Recognition: identify whether a peripherally presented stimulus is a face or an object.
    • Motion Discrimination: discriminate the direction of the peripherally presented moving dots.

    Performance on both tasks will be measured at visual field locations targeted by brain stimulation and at control visual field locations not targeted by brain stimulation.

  3. Quality of Life Change

    Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)

    Change in quality of life evaluated using the National Eye Institute 25 Item Visual Function Questionnaire (NEI-VFQ 25). Scores range from 0 to 100, with higher scores indicating better vision-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyungji Moon, MS

CONTACT

[email protected]

2027849949

Tina Liu, PhD

CONTACT

[email protected]

2027849920

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Registry information

Official study title

Vision Improvement Through Behavioral Rehabilitation And Neuroplasticity Training

Acronym: VIBRANT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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