Transcranial Ultrasound Stimulation for Cognitive Function Modulation in Patients With Post COVID-19 Brain Fog
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
sham transcranial ultrasound stimulation
DeviceIn 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
DeviceUltrasound 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: sham stimulation groupSham comparator 1 intervention
Group B: real TUS groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
false alarm rate change
false alarm rate change
Time frame
Day 1, Day 22
accuracy change
accuracy change
Time frame
Day 1, Day 2Secondary outcomes
1
false alarm rate
false alarm rate
Time frame
Day 12
accuracy
accuracy
Time frame
Day 13
cRDM modeling metrics
cRDM modeling metrics
Time frame
Day 14
Neural activation pattern of EEG
Neural activation pattern of EEG
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov