Recruiting

Multisensory Training

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05894434

Conditions

Hemianopia, Homonymous

Cortical Blindness, Unspecified Side of Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multisensory Training

Unisensory Training

Study Details

Brief summary:

This study seeks to determine the extent of the visual capabilities that can be restored in hemianopic stroke patients by a multisensory training technique and evaluate changes in the brain that the training induces. The effectiveness of the technique will be evaluated in two interventional contexts: patients whose blindness is long-standing and stable, and another in which intervention is as soon as possible after the stroke.

Conditions

Hemianopia, Homonymous

Cortical Blindness, Unspecified Side of Brain

Study ID

NCT05894434

Start date

Aug 29, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18 years old
  • Homonymous hemianopia diagnosed and referred by a neurologist, confirmed with Humphrey test (Goldmann size V) on first visit. Hemianopia must have been evident for at least 6 months for inclusion in the first experiment and <1 month for inclusion in the second
  • Cognitively normal, defined as having normal activities of daily living OR has received a cognitive adjudication of normal through the Wake Forest University School of Medicine or equivalent within the past 12 months
  • MRI compatible
  • Has reliable transportation or is able to use transportation provided by the study
  • English speaking

Exclusion Criteria:

  • Current major medical problems that might independently affect cognition, vision, or interfere with ability to attend study visits. This includes pathology of the retina or optic nerve explanatory of blindness
  • Unable or unwilling to attend scheduled testing and training sessions, including the 12 month follow up
  • Current diagnosis of a major neurological disorder that could interfere with the ability to follow task instructions (Dementia, Parkinson's disease, etc.) or that may interfere with the rehabilitation paradigm (uncorrected asymmetric hearing loss, deafness, hemineglect)
  • Unwilling or unable to provide consent for study participation
  • Current stroke symptoms deemed exclusionary by a study physician. This will be reviewed on a case-by-case basis by a study physician to determine whether factors may affect study outcomes, aims, or integrity
  • Taking medication that could negatively influence safety during the intervention
  • Enrolled in another interventional research study <= 3 months prior to beginning this study
  • Self-reports regularly drinking > 14 alcoholic beverages a week or current illicit drug use

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard Intervention: Multisensory Training

Patients with stable hemianopia (>6 months) are given multisensory training

active comparator: Standard Intervention: Unisensory Training

Patients with stable hemianopia (>6 months) are given auditory training and crossover to multisensory training

experimental: Early Intervention: Multisensory Training

Patients with early hemianopia (<1 months) are given multisensory training

active comparator: Early Intervention: Unisensory Training

Patients with early hemianopia (<1 months) are given auditory training and crossover to multisensory training

Interventions

Multisensory Training

The procedure involves repeatedly presenting identical visual-auditory stimuli at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°). The visual (a 500 ms flash) and auditory (500 ms broadband noise burst) stimuli are in spatial and temporal congruence.

Unisensory Training

The procedure involves repeatedly presenting identical auditory stimuli (500 ms broadband noise burst) at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°).

Primary outcome measure

  • Clinical Ophthalmological Test Scores [ Time Frame: Baseline ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Day 15 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 8 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 10 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 16 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 48 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 50 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 56 ]
  • Clinical Ophthalmological Test Scores [ Time Frame: Week 64 ]
  • Visual Perception Test Scores [ Time Frame: Baseline ]
  • Visual Perception Test Scores [ Time Frame: Day 15 ]
  • Visual Perception Test Scores [ Time Frame: Week 8 ]
  • Visual Perception Test Scores [ Time Frame: Week 10 ]
  • Visual Perception Test Scores [ Time Frame: Week 16 ]
  • Visual Perception Test Scores [ Time Frame: Week 48 ]
  • Visual Perception Test Scores [ Time Frame: Week 50 ]
  • Visual Perception Test Scores [ Time Frame: Week 56 ]
  • Visual Perception Test Scores [ Time Frame: Week 64 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Baseline ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Day 15 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 8 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 10 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 16 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 48 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 50 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 56 ]
  • Functional magnetic resonance imaging (fMRI) scans [ Time Frame: Week 64 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Baseline ]
  • Quality of Life (QoL) Assessment [ Time Frame: Day 15 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 8 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 10 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 16 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 48 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 50 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 56 ]
  • Quality of Life (QoL) Assessment [ Time Frame: Week 64 ]

Central Contacts and Locations

Central contacts

Locations

Wake Forest University School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Benjamin A Rowland, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 30, 2026

Last verified

Feb, 2026

Keywords

  • multisensory
  • visual perception
  • neurorehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.