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Recruiting NCT07105358

Visual Plasticity Following Brain Lesions

No phase Interventional Visual Field Defect Stroke Hemianopia Quadrantanopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcranial random noise stimulation (tRNS), Sham Stimulation, Perceptual learning-based training.
Who it may be relevant to
Registry conditions: Visual Field Defect, Stroke, Hemianopia, Quadrantanopia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Vision Improvement Through Behavioral Rehabilitation And Neuroplasticity Training

Overview

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.

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.

Primary outcome measures

  • Change in Motion Discrimination Performance [Time frame: Study visit 1 to 2 (within a week), and study visit 3 to 4 (within a week)]
Secondary outcome measures (3)
  • Visual Field Change [Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)]
  • Visual Perception Change [Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)]
  • Quality of Life Change [Time frame: Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Georgetown University Medical Center — Washington D.C.

Identifiers

NCT: NCT07105358 · STUDY00008292

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗