Visual Plasticity Following Brain Lesions

NCT ID: NCT07105358

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
This study is double-blind, meaning that both the participants and the researchers will be blinded to the treatment conditions.

Study Groups

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tRNS with perceptual learning-based training

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

Group Type EXPERIMENTAL

transcranial random noise stimulation (tRNS)

Intervention Type DEVICE

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

Perceptual learning-based training

Intervention Type BEHAVIORAL

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

Sham with perceptual learning-based training

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

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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transcranial random noise stimulation (tRNS)

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

Intervention Type DEVICE

Sham Stimulation

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.

Intervention Type DEVICE

Perceptual learning-based training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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

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):


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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Georgetown University Medical Center

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tina Liu, PhD

Role: CONTACT

2027849920

Kyungji Moon, MS

Role: CONTACT

2027849949

Facility Contacts

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Visual Perception and Plasticity Lab

Role: primary

202-784-9949

Other Identifiers

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STUDY00008292

Identifier Type: -

Identifier Source: org_study_id

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