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

Not Applicable

Recruiting

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

• Registration Number: NCT07154199
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This study aims to investigate whether a specific brain region mediates the cognitive deficit in long COVID brain fog, and whether targeted modulation of this region can improve cognition.

In observational study, the objective was to identify potential intervention targets for patients with long COVID brain fog. A total of 120 patients with long COVID were enrolled. Brain fog (BF) severity was quantified using the Brain Fog Assessment (BFA). Participants completed a continuous random-dot motion (cRDM) task during 128-channel electroencephalography (EEG) and underwent structural MRI and standardized neuropsychological testing.

In interventional study, 40 participants with persistent BF symptoms were enrolled for transcranial ultrasound stimulation (TUS). On Day 1, participants completed the BFA and provided demographic data, then performed the baseline cRDM task; 20 minutes later, structural MRI and baseline resting-state MRI were acquired. On Day 2, participants received 60 seconds of TUS (active or sham) according to randomized allocation. Twenty minutes post-stimulation, an 8-minute resting-state MRI scan was obtained, followed immediately by the follow-up cRDM task.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Status Verified: 2025-08
• Study First Submitted: 2025-08-24
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
false alarm rate change	Day 1, Day 2	false alarm rate change
accuracy change	Day 1, Day 2	accuracy change

Secondary Outcome Measures

Name	Time	Method
false alarm rate	Day 1	false alarm rate
accuracy	Day 1	accuracy
cRDM modeling metrics	Day 1	cRDM modeling metrics
Neural activation pattern of EEG	Day 1	Neural activation pattern of EEG
Brain structure indicator of MRI	Day 1	Brain structure indicator of MRI
resting-state functional connectivity change in MRI	Day 1, Day 2	resting-state functional connectivity change in MRI

Trial Locations

Locations (2)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China

Shandong Daizhuang Hospital; 🇨🇳 Jining, Shandong, China