Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After Stroke

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Low-intensity focused ultrasound
  Low-intensity focused Ultrasound (LIFU) is a noninvasive brain stimulation technique that uses low-intensity ultrasound to stimulate specific parts of the brain.
• Устройство Immersive virtual reality
  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.
• Устройство Inactive Low-intensity focused ultrasound
  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.

Первичные конечные точки

• Visual Field Change [Срок оценки: From enrollment to the 30 days after the end of treatment.]

Вторичные конечные точки (2)

• Quality of Life Change [Срок оценки: From enrollment to the 30 days after the end of treatment.]
• Hemodynamic response change [Срок оценки: From enrollment to the 30 days after the end of treatment.]

Критерии участия

Критерии включения

• ≥ 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke University Health System — Durham

Идентификаторы

NCT: NCT06875206 · Pro00115941

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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