Visual Plasticity Following Brain Lesions

NCT07105358 | Recruiting FDA Device

• 1 other identifier: STUDY00008292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Motion Discrimination Performance

  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.

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

Secondary Outcomes (3)

• Visual Field Change

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

• Visual Perception Change

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

• Quality of Life Change

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

Study Arms (2)

tRNS with perceptual learning-based training

EXPERIMENTAL

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

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

Sham with perceptual learning-based training

SHAM COMPARATOR

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

Device: Sham Stimulation; Behavioral: Perceptual learning-based training

Interventions

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.

tRNS with perceptual learning-based training

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.

Sham with perceptual learning-based training

Perceptual learning-based training BEHAVIORAL

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

Sham with perceptual learning-based training; tRNS with perceptual learning-based training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University Medical Center

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

RECRUITING

MeSH Terms

Conditions

Stroke; Hemianopsia; Blindness, Cortical; Brain Neoplasms; Brain Injuries, Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Tina Liu, PhD

CONTACT

2027849920; tina.liu@georgetown.edu

Kyungji Moon, MS

CONTACT

2027849949; vpplab@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is double-blind, meaning that both the participants and the researchers will be blinded to the treatment conditions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Initial 2-Day Sessions: Participants receive either real or sham transcranial random noise stimulation (tRNS) combined with perceptual learning-based training. 2. Washout Period: A minimum 1-week washout period (typically around 2 weeks) is included to minimize potential carry-over effects. 3. Final 2-Day Sessions: Participants complete the alternate stimulation condition (sham or real) paired with perceptual learning-based training.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 5, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

US (1)