StrokeLIFU-IVRNCT06875206
Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
A study testing Low-intensity focused ultrasound, Immersive virtual reality and Inactive Low-intensity focused ultrasound in people with Stroke and Visual Field Defect, run by Duke University at 1 site in United States.
Trial summary
This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Visual Field Defect, Visual Field Defect Following Cerebrovascular Accident
- What is being tested?
- Low-intensity focused ultrasound, Immersive virtual reality and Inactive Low-intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years old of any gender and race
- Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 6-24 months ago
- Partial or complete homonymous hemianopsia on clinical exam
Who cannot join
- Documented history of severe dementia with or without medication before stroke that affect subject's ability to participate in and be compliant to study protocol
- Significant upper motor deficits and the subject cannot do IVR sessions at the baseline
- History of seizures
- Inability to get a new MRI
- Presence of any ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of ultrasonic stimulation on the fetus is unknown); preexisting scalp lesion or wound or bone defect or hemicraniectomy.
- Patients will be excluded if they have a previous diagnosis of hemianopsia, a new diagnosis of central retinal ischemic injury, or visual blindness or a history of any other ocular disease.
- Concerns about the inability to complete study visits/procedures by the PI.
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
Duke University Health System
Durham, North Carolina, 27710
About this study
This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy.
The purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.
Read the detailed description
Randomization visit and 1st Intervention visit:
The randomization visit and 1st intervention vision will be on the same day. Participants will be "randomized" into one of the study groups described below.
- Group 1 (Sham Group): Inactive LIFU + VR
- Group 2 (Active Group): LIFU + VR Neither the subject nor the researcher conducting this study will know which group participants are in.
Sham LIFU: The setup is similar for the active stimulation group, except that a high acoustic impedance disk will be placed between the LIFU probe and the scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. The audible sound is nearly identical for both the sham and active stimulation.
Intervention visits (9 sessions over 21 days, about 2.5 hours per visit):
At these visits, participants will undergo the investigational study interventions.
There will be 30 minutes of a VR session and 20 minutes of active LIFU or inactive LIFU treatments.
- Conditions
- Stroke, Visual Field Defect, Visual Field Defect Following Cerebrovascular Accident, Hemianopia, Quadrantanopia, Occipital Lobe Infarct
- Being tested
- Low-intensity focused ultrasound, Immersive virtual reality, Inactive Low-intensity focused ultrasound
- Keywords
- virtual reality, stroke, visual deficit, chronic stroke, ultrasound stimulation, neuromodulation, stroke recovery, visual field defect, funcational imaging
- Medical subject headings
- Stroke, Hemianopsia, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity focused ultrasoundDevice
Also called LIFU
Low-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain.
Immersive virtual realityDevice
Also called IVR
IVR is a noninvasive, computer-based audiovisual therapy designed to enhance visual function. Using a VR headset, the system delivers targeted visual stimulation through an interactive game that the participant engages with during each session.
Inactive Low-intensity focused ultrasoundDevice
High acoustic impedance disk placed between LIFU and scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain.
| Study group | Role | What they receive |
|---|---|---|
| LIFUS with IVR | Experimental | Participants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy. Receives: Device: Low-intensity focused ultrasound; Device: Immersive virtual reality |
| Inactive LIFUS with IVR | Sham comparator | The participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy Receives: Device: Immersive virtual reality; Device: Inactive Low-intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Field Change
Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset
Measured: From enrollment to the 30 days after the end of treatment.
Secondary outcomes (2)
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)
Measured: From enrollment to the 30 days after the end of treatment.
Hemodynamic response change
Change in oxygenated hemoglobin concentration or blood-oxygen-level-dependent (BOLD) signal response from baseline and after intervention
Measured: From enrollment to the 30 days after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875206
- Sponsor's protocol ID
- Pro00115941
- Acronym
- LIFU-IVR
- Status last verified
- May 2026
- First submitted
- 11 Feb 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke
- ClinicalTrials.gov ID
- NCT06875206
- Acronym / sponsor ID
- LIFU-IVR / Pro00115941
- Conditions
- Stroke, Visual Field Defect, Visual Field Defect Following Cerebrovascular Accident, Hemianopia, Quadrantanopia, Occipital Lobe Infarct
- Keywords
- virtual reality, stroke, visual deficit, chronic stroke, ultrasound stimulation, neuromodulation, stroke recovery, visual field defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will explore if brain stimulation combined with virtual reality therapy improves visual impairment. The stimulation technique is called low-intensity focused ultrasound stimulation (LIFUS). The treatment uses ultrasound to stimulate vision specific parts of the brain. Before this therapy, the participants will get structural brain imaging. Functional brain imaging will be performed before and after the study's completion to measure brain activity response to therapy.
The purpose of this research study is to evaluate patients who have had a stroke between 6 and 24 months ago with a visual field impairment. The duration of active participation in the study is 1.5 months.
Detailed description
Randomization visit and 1st Intervention visit:
The randomization visit and 1st intervention vision will be on the same day. Participants will be "randomized" into one of the study groups described below.
- Group 1 (Sham Group): Inactive LIFU + VR
- Group 2 (Active Group): LIFU + VR Neither the subject nor the researcher conducting this study will know which group participants are in.
Sham LIFU: The setup is similar for the active stimulation group, except that a high acoustic impedance disk will be placed between the LIFU probe and the scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. The audible sound is nearly identical for both the sham and active stimulation.
Intervention visits (9 sessions over 21 days, about 2.5 hours per visit):
At these visits, participants will undergo the investigational study interventions.
There will be 30 minutes of a VR session and 20 minutes of active LIFU or inactive LIFU treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIFUS with IVR | Experimental | Device: Low-intensity focused ultrasound, Device: Immersive virtual realityParticipants are randomized to the active group will undergo active Low intensity-focused ultrasound stimulation (LIFUS) combined with Immersive Virtual Reality (IVR) therapy. |
| Inactive LIFUS with IVR | Sham comparator | Device: Immersive virtual reality, Device: Inactive Low-intensity focused ultrasoundThe participants in the Sham group will undergo inactive low-intensity focused ultrasound stimulation combined with Immersive virtual reality therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old of any gender and race
- Clinical ischemic stroke or hemorrhagic (confirmed by CT or MRI) that occurred >= 6-24 months ago
- Partial or complete homonymous hemianopsia on clinical exam
Key exclusion criteria (7 listed)
- Documented history of severe dementia with or without medication before stroke that affect subject's ability to participate in and be compliant to study protocol
- Significant upper motor deficits and the subject cannot do IVR sessions at the baseline
- History of seizures
- Inability to get a new MRI
- Presence of any ultrasonic stimulation risk factors: an electrically, magnetically, or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, or any other electrically sensitive support system; non-fixed metal in any part of the body; pregnancy (the effect of ultrasonic stimulation on the fetus is unknown); preexisting scalp lesion or wound or bone defect or hemicraniectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity focused ultrasoundAlso: LIFULow-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain. | Device | LIFUS with IVR |
| Immersive virtual realityAlso: IVRIVR is a noninvasive, computer-based audiovisual therapy designed to enhance visual function. Using a VR headset, the system delivers targeted visual stimulation through an interactive game that the participant engages with during each session. | Device | Inactive LIFUS with IVR, LIFUS with IVR |
| Inactive Low-intensity focused ultrasoundHigh acoustic impedance disk placed between LIFU and scalp that mimics the audible sensation of a slight buzzing but attenuates more than 95% of the energy into the brain. | Device | Inactive LIFUS with IVR |
Primary outcome
Visual Field Change
Time frame: From enrollment to the 30 days after the end of treatment.
Change of the blind area in the visual fields as measured by visual perimetry implemented in a virtual reality (VR) headset
2 secondary outcomes
Quality of Life Change
Time frame: From enrollment to the 30 days after the end of treatment.
Hemodynamic response change
Time frame: From enrollment to the 30 days after the end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity focused ultrasound, Immersive virtual reality and Inactive Low-intensity focused ultrasound in people with Stroke and Visual Field Defect, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Gonzalez, MSCR (919-668-7597, megan.gonzalez@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Field Change (time frame: From enrollment to the 30 days after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.