Is NCT05085210 recruiting in Boston, MA?

Yes, NCT05085210 is currently recruiting participants at its Boston, MA location. This visual field defect, peripheral clinical trial is actively enrolling qualified participants.

How do I join the visual field defect, peripheral clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Visual Field Defect, Peripheral Clinical Trial in Boston, MA

About This Visual Field Defect, Peripheral Study in Boston

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.

Sponsor: Beth Israel Deaconess Medical Center

Who Can Participate

Inclusion Criteria

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 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.

Exclusion Criteria

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.

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.

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.

Subjects 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 with a history of seizures are already excluded per the above criteria.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05085210) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Visual Field Defect, Peripheral Treatment Options in Boston, MA

If you're searching for visual field defect, peripheral treatment options in Boston, MA, this clinical trial (NCT05085210) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced visual field defect, peripheral specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all visual field defect, peripheral clinical trials near you to find additional studies recruiting in your area.

Visual Field Defect, Peripheral Clinical Trial in Boston, MA

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