Stroke Clinical Trial
Official title:
Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery
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. Finally, although results will vary among participants depending on the extension 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 1 will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic and subacute VFD stroke participant, and (ii) longitudinal testing up to 6 months post-treatment. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | October 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field. - Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry. - 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 - Radiologic evidence that the stroke was hemorrhagic or non-vascular in nature - Visual cortex damage 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 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 (central nervous system) 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) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Motion Discrimination Change | Change in the motion discrimination computer task after training within the blind visual field | After 10 days training/stimulation and after 6 months training/stimulation | |
Secondary | Quality of Life Change | Change as assessed by the National Eye Institute 25 Item Visual Function Questionnaire (NEI-VFQ 25). The NEI-VFQ is a vision based questionnaire which evaluates quality of life with respect to vision in everyday life. The NEI-VFQ has multiple sub-scales for different areas of life, such as Near-Vision, General Health, or Ocular Pain. Each scale is scored from 0 to 100 with 100 representing the best possible score (perfect health or ability) | After 10 days training/stimulation and after 6 months training/stimulation | |
Secondary | Visual Field Change | Change of the blind area in the visual fields as measured by Humphrey perimetry. | After 10 days training/stimulation and after 6 months training/stimulation |
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