Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Jan 2023
Longer than P75 for not_applicable covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2023
CompletedFirst Submitted
Initial submission to the registry
August 24, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 4, 2025
August 1, 2025
4.9 years
August 24, 2025
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
false alarm rate change
false alarm rate change
Day 1, Day 2
accuracy change
accuracy change
Day 1, Day 2
Secondary Outcomes (6)
false alarm rate
Day 1
accuracy
Day 1
cRDM modeling metrics
Day 1
Neural activation pattern of EEG
Day 1
Brain structure indicator of MRI
Day 1
- +1 more secondary outcomes
Study Arms (2)
sham stimulation group
SHAM COMPARATORIn the sham group, the transducer power was turned off, pre-recorded pulse repetition sounds were played to control for auditory confounds. The equipment appearance is consistent with the device. Single stimulation, 60 seconds.
real TUS group
EXPERIMENTALUltrasound stimulation was delivered using TPO-203 and H-104MR\_4AA-4CH transducer (Sonic Concepts, Woodinville, WA, USA). The target free-field spatial peak pulse-average intensity was maintained at 33.85 W/cm². The stimulation target is the right inferior Insula, according the results from observational study.
Interventions
In the sham group, the transducer power was turned off, pre-recorded pulse repetition sounds were played to control for auditory confounds. The equipment appearance is consistent with the test device. Single stimulation, 60 seconds.
Ultrasound stimulation was delivered using TPO-203 and H-104MR\_4AA-4CH transducer (Sonic Concepts, Woodinville, WA, USA). In the real stimulation group, theta-burst TUS (Yaakub et al., 2024; Yaakub et al., 2023) was performed with the following parameters: pulse duration = 20 ms; pulse repetition interval = 200 ms; total duration = 80 s. The target free-field spatial peak pulse-average intensity was maintained at 33.85 W/cm². The stimulation target was defined as the overlapping region between the source localisation results and the right inferior insula in the Destrieux atlas
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. Presence of any symptoms of cognitive impairment or other neurological symptoms prior to COVID-19 infection;
- \. Structural MRI revealing significant intracranial lesions or structural abnormalities;
- \. Development of severe neurological complications after COVID-19 infection, including delirium, cerebrovascular diseases, encephalitis, and epilepsy;
- \. Other disorders that may cause cognitive impairment, including Dementia, Schizophrenia spectrum disorders, stroke, Alzheimer's disease, and Parkinson's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Shandong Daizhuang Hospital
Jining, Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Tang, MD., PhD
Xuanwu Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2025
First Posted
September 4, 2025
Study Start
January 6, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share