Neglect, HemispatialNCT06483230
Implementation of IVS3 for Upper Limb Motor Recovery
A study testing Intensive Visual Stimulation Device in people with Neglect, Hemispatial and Stroke, Cardiovascular, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neglect, Hemispatial, Stroke, Cardiovascular, Mirror Movement
- What is being tested?
- Intensive Visual Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- English speaking
- History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
- FMA-UE: 20 < x < 50 (moderate impairments)
- With or without hemi spatial neglect
Who cannot join
- Spasticity or increased tone with MAS ≥3 in the upper extremity
- Unable to communicate effectively or provide informed consent
- Significant visual impairments
- Concurrent occupational therapy being received outside of the study
- Pregnant or incarcerated individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
New York, New York, 10065
Joan Stilling, MD
Joan Stilling, MD, MS
About this study
Official title: A Pilot Study on Tolerance and Ease of Implementation of Intensive Visual Stimulation (IVS3) in Daily Practice for Upper Limb Motor Recovery in Outpatient Rehab Center
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.
Read the detailed description
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).
- Being tested
- Intensive Visual Stimulation Device
- Medical subject headings
- Perceptual Disorders, Myocardial Infarction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Visual Stimulation DeviceDevice
Also called IVS3 (model number 2022.02.IVS3.013)
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemi-spatial Neglect | Experimental | Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests. Receives: Device: Intensive Visual Stimulation Device |
| No hemi-spatial neglect | Active comparator | Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests. Receives: Device: Intensive Visual Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 treatment sessions over 4-6 weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start2 Oct 2024
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neglect, HemispatialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Dessintey Inc.
- Responsible party
- Sponsor
- Investigators
- Joan Stilling, MD,MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483230
- Sponsor's protocol ID
- 24-04027379
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures).