Improving Visual Field Deficits With Noninvasive Brain Stimulation

NCT05085210 | Recruiting FDA Device

• 1 other identifier: 2021P000804
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.

Conditions

Visual Field Defect, Peripheral; Stroke; Visual Impairment; Hemianopsia; Quadrantanopia; Cortical Blindness; Visual Field Defect Homonymous Bilateral; Occipital Lobe Infarct; Visual Fields Hemianopsia

Keywords

Visual Field defects; Occipital Stroke; Ischemic Stroke; visual cortex; noninvasive brain stimulation; transcranial direct current stimulation; visual training; visual recovery; vision loss; quadrantanopia; Hemorrhagic stroke

Outcome Measures

Primary Outcomes (1)

• Visual Motion Discrimination Change

  Change in the motion discrimination computer or VR task after training within the blind visual field

  After 10 days training/stimulation and after 6 months training/stimulation

Secondary Outcomes (2)

• Quality of Life Change

  After 10 days training/stimulation and after 6 months training/stimulation

• Visual Field Change

  After 10 days training/stimulation and after 6 months training/stimulation

Study Arms (5)

Computer Visual Training with Noninvasive Brain Stimulation

EXPERIMENTAL

10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer

Device: transcranial random noise stimulation (tRNS); Behavioral: Computer Based Visual Training

Visual Training with Sham Stimulation

EXPERIMENTAL

10 daily (Monday-Friday) 20-30 minute sessions of sham stimulation with visual training on the computer

Behavioral: Computer Based Visual Training; Device: Sham stimulation

Noninvasive Brain Stimulation without visual training

EXPERIMENTAL

10 daily (Monday-Friday) 20-30 minute sessions of tRNS alone

Device: transcranial random noise stimulation (tRNS)

Sham Stimulation without visual training

SHAM COMPARATOR

Placebo control. Simulation of tRNS without receiving any actual stimulation

Device: Sham stimulation

VR Visual Training with Noninvasive Brain Stimulation

EXPERIMENTAL

10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer

Device: transcranial random noise stimulation (tRNS); Behavioral: Virtual Reality Based Visual Training

Interventions

transcranial random noise stimulation (tRNS) DEVICE

noninvasive current stimulation for 20 - 30 minutes stimulation on visual cortex (electrodes on surface of scalp, positioned O1 / O2 on EEG cap). 1mA max amplitude noise stimulation, frequencies from 100 Hz - 640 Hz.

Computer Visual Training with Noninvasive Brain Stimulation; Noninvasive Brain Stimulation without visual training; VR Visual Training with Noninvasive Brain Stimulation

Computer Based Visual Training BEHAVIORAL

Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center of screen during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

Computer Visual Training with Noninvasive Brain Stimulation; Visual Training with Sham Stimulation

Sham stimulation DEVICE

20-30 minutes sham stimulation on visual cortex. Participants receive identical setup to real stimulation. The device provides a short ramp on period to simulate the feeling of real stimulation at the start but no current is delivered otherwise.

Sham Stimulation without visual training; Visual Training with Sham Stimulation

Virtual Reality Based Visual Training BEHAVIORAL

• Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center point within the VR headset during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

VR Visual Training with Noninvasive Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Presence of some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist.
• First ever ischemic or hemorrhagic stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field.
• Ischemic stroke patients will be either subacute (within 6 months of their stroke) or chronic (more than 6 months)
• Hemorrhagic stroke patients will be chronic only (greater than 6 months)
• Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry.
• Imaging evidence that the stroke is primarily affecting the visual cortex.
• Willing and able to participate in the study protocol and to comply with study procedures.

You may not qualify if:

• No evidence of damage to the primary visual cortex.
• Visual cortex damage as a result of a subsequent stroke (not primary).
• Total cortical blindness, covering both left and right visual fields.
• Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed.
• Complete loss of reading abilities.
• Current or prior history of any neurological disorder other than stroke, such as epilepsy, a progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions other than the qualifying stroke lesion.
• Current history of poorly controlled migraines including chronic medication for migraine prevention.
• History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or immediate (1st degree relative) family history of epilepsy; with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator.
• History of fainting spells of unknown or undetermined etiology that might constitute seizures.
• Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
• Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks.
• Contraindication for receiving tRNS.
• Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
• Any complex, uncontrolled/unstable or terminal medical illness.
• Substance abuse or dependence within the past six months.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Stroke; Vision Disorders; Hemianopsia; Blindness, Cortical; Ischemic Stroke; Hemorrhagic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blindness

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lorella Battelli, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorella Battelli, PhD

CONTACT

617-667-0326; lbattell@bidmc.harvard.edu

Meghna Uzgare, BS

CONTACT

(617) 667-0362; muzgare@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Group 1b is guaranteed actual stimulation. Randomization for sham vs actual stimulation will be conducted by a predetermined member of the research team, ensuring that participants, care providers, investigators and outcome assessors all remain blinded to the intervention at the time of each assessment. Given this is a pilot study and that both groups receive randomization over the type of stimulation we do not anticipate that randomization for enrolling subjects into group 1 or 2 is necessary.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a pilot interventional study in patients with visual field deficit (VFD). Participants will undergo a screening evaluation that includes a neuro-ophthalmologic, cognitive and medical assessment, a confirmation of ischemic or hemorrhagic stroke diagnosis with subsequent VFD including verification of prior clinical imaging. Baseline assessments will consist of visual field perimetry, quality of life assessments and EEG/MRI for Groups 1a and 2. Group 1a aims to examine the effects of two weeks (10 days) of visual training with tRNS vs visual training with sham tRNS. Group 1b aims to examine the effects of two weeks (10 days) of visual training in a virtual reality environment with tRNS. Group 2 aims to examine the effects of two weeks (10 days) of tRNS vs 2 weeks of sham tRNS (no visual training in this group).

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: January 25, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)