RECRUITING

Improving Visual Field Deficits With Noninvasive Brain Stimulation

Conditions

Visual Field Defect, Peripheral Stroke Visual Impairment Hemianopsia Quadrantanopia Cortical Blindness Visual Field Defect Homonymous Bilateral Occipital Lobe Infarct Visual Fields Hemianopsia Visual Field defects Occipital Stroke Ischemic Stroke visual cortex noninvasive brain stimulation transcranial direct current stimulation visual training visual recovery vision loss Hemorrhagic stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery

Quick Facts

Study Start:2022-01-25

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05085210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years of age or older. 2. 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. 3. 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) 4. Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry. 5. Imaging evidence that the stroke is primarily affecting the visual cortex. 6. Willing and able to participate in the study protocol and to comply with study procedures.	1. No evidence of damage to the primary visual cortex. 2. Visual cortex damage as a result of a subsequent stroke (not primary). 3. Total cortical blindness, covering both left and right visual fields. 4. Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed. 5. Complete loss of reading abilities. 6. 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. 7. Current history of poorly controlled migraines including chronic medication for migraine prevention. 8. 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. 9. History of fainting spells of unknown or undetermined etiology that might constitute seizures. 10. Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition. 11. Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks. 12. Contraindication for receiving tRNS. 13. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.). 14. Any complex, uncontrolled/unstable or terminal medical illness. 15. Substance abuse or dependence within the past six months. 16. Medications will be reviewed by the responsible MD (Drs. Sandeep Kumar or Dan Press) and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS active drugs. 17. All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study. 18. Subjects who, in the investigator's opinion, might not be suitable for the study. 19. A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig). 20. Additional criteria for Group 1b only: Contraindication for using VR technology, specifically an implanted medical device such as a pacemaker, implanted defibrillator, deep brain or vagal nerve stimulator. Participants with a history of seizures are already excluded per the above criteria.

Inclusion Criteria

Exclusion Criteria

1. 18 years of age or older.
2. 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.
3. 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)
4. Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry.
5. Imaging evidence that the stroke is primarily affecting the visual cortex.
6. Willing and able to participate in the study protocol and to comply with study procedures.

1. No evidence of damage to the primary visual cortex.
2. Visual cortex damage as a result of a subsequent stroke (not primary).
3. Total cortical blindness, covering both left and right visual fields.
4. Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed.
5. Complete loss of reading abilities.
6. 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.
7. Current history of poorly controlled migraines including chronic medication for migraine prevention.
8. 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.
9. History of fainting spells of unknown or undetermined etiology that might constitute seizures.
10. Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition.
11. Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks.
12. Contraindication for receiving tRNS.
13. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
14. Any complex, uncontrolled/unstable or terminal medical illness.
15. Substance abuse or dependence within the past six months.
16. Medications will be reviewed by the responsible MD (Drs. Sandeep Kumar or Dan Press) and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS active drugs.
17. All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study.
18. Subjects who, in the investigator's opinion, might not be suitable for the study.
19. A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig).
20. Additional criteria for Group 1b only: Contraindication for using VR technology, specifically an implanted medical device such as a pacemaker, implanted defibrillator, deep brain or vagal nerve stimulator. Participants with a history of seizures are already excluded per the above criteria.

Contacts and Locations

Study Contact

Lorella Battelli, PhD

CONTACT

617-667-0326

lbattell@bidmc.harvard.edu

Aya Kamel, BS

CONTACT

(617) 667-0362

akamel@bidmc.harvard.edu

Principal Investigator

Lorella Battelli, PhD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Lorella Battelli, PhD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-25

Study Completion Date2025-10

Study Record Updates

Study Start Date2022-01-25

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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