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New treatment option for Visual Field Defect, Peripheral
Official title Improving Visual Field Deficits With Noninvasive Brain Stimulation
ClinicalTrials.gov ID: NCT05085210
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 18 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...
- 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)
You likely can't join 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)...
See the full eligibility criteria
Who can join
- 18 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...
- 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.
What rules you out
- 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...
- 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.
- 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...
- 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.
- people who, in the investigator's opinion, might not be suitable for the study.
- 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).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.