Brain Fog, COVID-19, Long COVID, Transcranial Ultrasound Stimulation
Conditions
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.
Interventions
DEVICEsham transcranial ultrasound stimulation
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.
DEVICEreal transcranial ultrasound stimulation
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
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| false alarm rate change | Day 1, Day 2 | false alarm rate change |
| accuracy change | Day 1, Day 2 | accuracy change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cRDM modeling metrics | Day 1 | cRDM modeling metrics |
| Neural activation pattern of EEG | Day 1 | Neural activation pattern of EEG |
| false alarm rate | Day 1 | false alarm rate |
| resting-state functional connectivity change in MRI | Day 1, Day 2 | resting-state functional connectivity change in MRI |
| Brain structure indicator of MRI | Day 1 | Brain structure indicator of MRI |
| accuracy | Day 1 | accuracy |
Countries
China
Contacts
Primary ContactYi Tang, MD., PhD
Backup ContactShaojiong Zhou, MD.
Outcome results
None listed