Visual Plasticity Following Brain Lesions

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07105358
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Georgetown University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Visual Field Defect, Stroke, Hemianopia, Quadrantanopia, Cortical Blindness, Brain Tumor, Traumatic Brain Injury, Visual Field Defect, Peripheral

Arms & Interventions

Arms

Experimental: 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.

Sham Comparator: 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.

Interventions

Device: - 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.

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.

Behavioral: - Perceptual learning-based training

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Georgetown University Medical Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Recruiting

Address

Georgetown University Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20057

Site Contact

Visual Perception and Plasticity Lab

[email protected]

202-784-9949

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