Recruiting

IVS3

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06483230

Conditions

Neglect, Hemispatial

Stroke, Cardiovascular

Mirror Movement

Motor Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intensive Visual Stimulation Device

Study Details

Brief 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.

Conditions

Neglect, Hemispatial

Stroke, Cardiovascular

Mirror Movement

Motor Activity

Study ID

NCT06483230

Start date

Oct 2, 2024

Status verified date

Oct, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years old
2. English speaking
3. History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
4. FMA-UE: 20 < x < 50 (moderate impairments)
5. With or without hemi spatial neglect

Exclusion Criteria:

1. Spasticity or increased tone with MAS ≥3 in the upper extremity
2. Unable to communicate effectively or provide informed consent
3. Significant visual impairments
4. Concurrent occupational therapy being received outside of the study
5. Pregnant or incarcerated individuals

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hemi-spatial Neglect

Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.

active comparator: No hemi-spatial neglect

Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Interventions

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.

Primary outcome measure

  • Mean number of sessions attended [ Time Frame: 12 treatment sessions over 4-6 weeks. ]
  • Number of serious adverse events [ Time Frame: 12 treatment sessions over 4-6 weeks. ]

Central Contacts and Locations

Central contacts

Zhiyan Yang, MS

(212) 746-1509zhy7009@med.cornell.edu

Locations

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Joan Stilling, MD, MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-29.