Focused ultrasound to improve thinking in post‑COVID brain fog

Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog

This project will see if short, targeted pulses of ultrasound to a specific brain area can improve thinking, attention, and other cognitive symptoms in people with persistent brain fog after COVID‑19.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07154199 on ClinicalTrials.gov

What this trial studies

The work combines an observational phase and a small interventional phase to find and test a brain region linked to long‑COVID cognitive problems. In the observational portion, 120 people with long‑COVID brain fog underwent cognitive testing, a continuous random‑dot motion task during 128‑channel EEG, and structural MRI to identify candidate targets. In the interventional portion, 40 participants with ongoing brain fog received either real or sham transcranial ultrasound stimulation targeted to the identified region, with baseline and post‑stimulation cognitive testing and MRI measures. Outcomes focus on changes in a Brain Fog Assessment score and task performance following a single short session of stimulation.

Who should consider this trial

Good fit: People who had a confirmed COVID‑19 infection and continue to have brain fog symptoms at least four weeks after acute illness, without prior cognitive disorders or major structural brain abnormalities on MRI, are the intended participants.

Not a fit: Patients with pre‑existing dementia, major psychiatric or neurological disorders, prior cognitive impairment before COVID, significant intracranial lesions on MRI, or those who developed severe neurological complications from COVID are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could offer a noninvasive way to reduce brain fog and improve attention and everyday thinking for people with long COVID.

How similar studies have performed: Early, small studies of transcranial ultrasound and other noninvasive brain stimulation techniques have shown preliminary, mixed signals for changing brain activity and cognition, but the approach remains experimental and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Patients should have a history of COVID-19 infection (positive test results for either polymerase chain reaction or rapid antigen test) and report persistent brain fog (BF) symptoms at least 4 weeks after recovering from acute COVID-19.

Exclusion Criteria:

* 1\. Presence of any symptoms of cognitive impairment or other neurological symptoms prior to COVID-19 infection;
* 2\. Structural MRI revealing significant intracranial lesions or structural abnormalities;
* 3\. Development of severe neurological complications after COVID-19 infection, including delirium, cerebrovascular diseases, encephalitis, and epilepsy;
* 4\. Other disorders that may cause cognitive impairment, including Dementia, Schizophrenia spectrum disorders, stroke, Alzheimer's disease, and Parkinson's disease.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Shandong Daizhuang Hospital — Jining, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Yi Tang, MD., PhD — Xuanwu Hospital, Beijing
• Study coordinator: Yi Tang, MD., PhD

Conditions COVID-19; Brain Fog; Long COVID; Transcranial Ultrasound Stimulation