An interventional study of Intensive Visual Stimulation Device in Neglect, Hemispatial, Stroke, Cardiovascular and Mirror Movement, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.
This study will investigate the implementation of the intensive visual stimulation three (IVS3) device in the outpatient rehabilitation setting. This is a phase I/II open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke (10 with hemi spatial neglect and 15 without), when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes, across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation (single site).
66 studies on the registry are indexed under Perceptual Disorders; 21 are open to participants now.
This study's planned enrollment of 25 is close to the median of 27 across 52 interventional studies indexed under Perceptual Disorders.
Browse Perceptual Disorders studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.
Device: Intensive Visual Stimulation Device
Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.
Device: Intensive Visual Stimulation Device
The therapist installs the patient in front of the device. First, patient puts the healthy side on the table and the therapist records several movements. The software of the device flips the video in order to create a mirrored image of the movement (pretty close to the mirror therapy approach). When all the movements are recorded, patient installs the affected side on the table and the screen is placed over the hand. Likewise, patient has the impression the hand is moving again. Thanks to this action observation principle, therapist can encourage the patient in trying to move again and increase brain plasticity.
Also known as: IVS3 (model number 2022.02.IVS3.013)
Mean number of sessions attended
The primary outcome measure is defined as the mean number of sessions attended of the planned twelve visits. Min 0, Max 12.
Time frame: 12 treatment sessions over 4-6 weeks.
Number of serious adverse events
The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device.
Time frame: 12 treatment sessions over 4-6 weeks.
Mean Client Satisfaction Questionnaire-8
Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
Time frame: Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean System Usability Scale (SUS)
Feasibility. This tool is a subjective therapist usability measure assessing satisfaction with implementation of the intervention. It is a 10 item likert scale, scored 0-100, with higher scores indicating greater satisfaction.
Time frame: Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean Star Ratio on Star Cancellation Test
Screening tool to detect unilateral spatial neglect. The maximum score that can be achieved on the test is 54 points (56 small stars in total minus the 2 used for demonstration). A cutoff of \< 44 indicates the presence of USN. A Laterality Index or Star Ratio can be calculated from the ratio of stars cancelled on the left of the page to the total number of stars cancelled. Scores between 0 and 0.46 indicate USN in the left hemispace. Scores between 0.54 and 1 indicate USN in the right hemispace
Time frame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean Distance from Midpoint on Line Bisection
Screening tool to detect unilateral spatial neglect. Patients are asked to place a mark with a pencil (with their preferred or unaffected hand) through the center of a series of 18 horizontal lines on an 11x 8.5-inch page. The test is scored by measuring the deviation of the bisection from the true center of the line. A deviation of more than 6 mm from the midpoint indicates USN. Omission of two or more lines on one half of the page indicates USN.
Time frame: Baseline, Post- treatment, 3 months post-treatment.Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean Change from baseline Fugl-Meyer Upper Extremity Assessment (FMAUE)
Assessment of upper extremity motor function. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Score ranges from 0-66 for the upper extremity (22 items).
Time frame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean Change from baseline Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.The ARAT is scored on a four-level ordinal scale (0-3). 0 = can not perform any part of the test, 1 = performs the test partially, 2 = completes the test, but takes abnormally long time, 3 = performs the test normally. Total score ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
Time frame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Mean change from baseline numeric pain rating scale (NPRS)
The NPRS measures the subjective intensity of pain. The NPRS is an 11-point scale scored from 0-10: 1\) "0" = no pain, 2) "10" = the most intense pain imaginable.
Time frame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 24 months following study publication
Access criteria: Investigators whose proposed use of data has been approved by an independent review committee for individual participant data meta-analyses. Data will be available 2 years following study publication.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Mar 2027, 29 months after the start.
Of 27 interventional studies with no phase under Perceptual Disorders, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 134. This study's planned 29 months is below that.
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