COVID-19NCT07154199
Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog
A study testing real transcranial ultrasound stimulation in people with COVID-19 and Brain Fog, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Brain Fog, Long COVID
- What is being tested?
- real transcranial ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jan 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shaojiong Zhou, MD. contact
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Tang, MD., PhD, 00861083198673, tangyixw@vip.163.com
Shaojiong Zhou, MD., shaojiongzhou@sina.com
- Recruiting
Shandong Daizhuang Hospital
Jining, Shandong
Kun Liu, MD, 19553700077, likunyjs@163.com
About this study
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.
- Conditions
- COVID-19, Brain Fog, Long COVID, Transcranial Ultrasound Stimulation
- Being tested
- sham transcranial ultrasound stimulation, real transcranial ultrasound stimulation
- Medical subject headings
- COVID-19, Mental Fatigue, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham transcranial ultrasound stimulationDevice
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.
real transcranial ultrasound stimulationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| sham stimulation group | Sham comparator | 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 device. Single stimulation, 60 seconds. Receives: Device: sham transcranial ultrasound stimulation |
| real TUS group | Experimental | Ultrasound 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. Receives: Device: real transcranial ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
false alarm rate change
false alarm rate change
Measured: Day 1, Day 2
accuracy change
accuracy change
Measured: Day 1, Day 2
Secondary outcomes (6)
false alarm rate
false alarm rate
Measured: Day 1
accuracy
accuracy
Measured: Day 1
cRDM modeling metrics
cRDM modeling metrics
Measured: Day 1
Neural activation pattern of EEG
Neural activation pattern of EEG
Measured: Day 1
Brain structure indicator of MRI
Brain structure indicator of MRI
Measured: Day 1
resting-state functional connectivity change in MRI
resting-state functional connectivity change in MRI
Measured: Day 1, Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start6 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, MD., PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154199
- Sponsor's protocol ID
- KS2022105-1
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog
- ClinicalTrials.gov ID
- NCT07154199
- Acronym / sponsor ID
- KS2022105-1
- Conditions
- COVID-19, Brain Fog, Long COVID, Transcranial Ultrasound Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham stimulation group | Sham comparator | Device: sham transcranial ultrasound stimulationIn 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 | Experimental | Device: real transcranial ultrasound stimulationUltrasound 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham transcranial ultrasound stimulationIn 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. | Device | sham stimulation group |
| real transcranial ultrasound stimulationUltrasound 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 | Device | real TUS group |
Primary outcome
false alarm rate change
Time frame: Day 1, Day 2
false alarm rate change
accuracy change
Time frame: Day 1, Day 2
accuracy change
6 secondary outcomes
false alarm rate
Time frame: Day 1
accuracy
Time frame: Day 1
cRDM modeling metrics
Time frame: Day 1
Neural activation pattern of EEG
Time frame: Day 1
Brain structure indicator of MRI
Time frame: Day 1
resting-state functional connectivity change in MRI
Time frame: Day 1, Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaojiong Zhou, MD. contact
Yi Tang, MD., PhD principal investigator
Xuanwu Hospital, Beijing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real transcranial ultrasound stimulation in people with COVID-19 and Brain Fog, run by Xuanwu Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, MD., PhD (00861083198673, tangyi@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
false alarm rate change (time frame: Day 1, Day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.