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Efficacy of transcranial-focused ultrasound stimulation of human visual cortex on visual improvement: a randomized sham-controlled trial

Efficacy of transcranial-focused ultrasound stimulation of human visual cortex on visual improvement: a randomized sham-controlled trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250505001
Enrollment
40
Registered
2025-05-05
Start date
2025-05-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with visual impairment, defined as those with visual acuity worse than 20/70 transcranial-focused ultrasound, ultrasound stimulation, visual cortex stimulation, blindness

Interventions

Transcranial focused ultrasound is a low-intensity ultrasound technique used for brain stimulation.,Participants in this group receive a procedure or device that appears identical to the actual treatm
Brain stimulation,Control

Sponsors

Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Lead Sponsor
Ramathibodi Foundation
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Adults age more than 18 years old. 2. Visual impairment, defined as those with visual acuity worse than 20/70. 3. Documented injury to the anterior visual pathway, including any pathology within the orbit, such as retina, optic nerve, and optic chiasm. 4. Having unilateral or bilateral involvement. 5. Brain MRI is available from routine clinical assessments. 6. Willing to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Having been diagnosed with dementia, encephalopathy, or alteration of consciousness. 2. Attention deficit includes inattention (difficulty maintaining focus), hyperactivity (excessive movement inappropriate to the setting), and impulsivity (acting hastily without consideration), assessed through clinical neurological examinations. 3. Having been prescribed the medications with a sedation effect such as benzodiazepine, high dose phenobarbital.

Design outcomes

Primary

MeasureTime frame
Visual acuity 30 minutes Snellen chart

Secondary

MeasureTime frame
Form perception 30 minutes Postitive or negative

Countries

Thailand

Contacts

Public ContactPanitha Jindahra

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

panitha.jin@mahidol.ac.th022011386

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026