Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07154199

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

COVID-19 Behavior Behavioral Symptoms Brain Fog Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Infections Long COVID Lung Diseases Mental Fatigue Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Transcranial Ultrasound Stimulation Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sham transcranial ultrasound stimulation

Device

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 stimulation

Device

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

Primary outcomes

  1. false alarm rate change

    Time frame: Day 1, Day 2

    false alarm rate change

  2. accuracy change

    Time frame: Day 1, Day 2

    accuracy change

Secondary outcomes

  1. false alarm rate

    Time frame: Day 1

    false alarm rate

  2. accuracy

    Time frame: Day 1

    accuracy

  3. cRDM modeling metrics

    Time frame: Day 1

    cRDM modeling metrics

  4. Neural activation pattern of EEG

    Time frame: Day 1

    Neural activation pattern of EEG

  5. Brain structure indicator of MRI

    Time frame: Day 1

    Brain structure indicator of MRI

  6. resting-state functional connectivity change in MRI

    Time frame: Day 1, Day 2

    resting-state functional connectivity change in MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Shaojiong Zhou, MD.

CONTACT

[email protected]

Yi Tang, MD., PhD

CONTACT

[email protected]

00861083198673

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.