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

Capital Medical University

Status: Enrolling

Conditions: COVID-19; Transcranial Ultrasound Stimulation; Long COVID; Brain Fog

Treatments: Device: sham transcranial ultrasound stimulation; Device: real transcranial ultrasound stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07154199

KS2022105-1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

sham stimulation group

Sham Comparator group

Description:

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.

Treatment:

Device: sham transcranial ultrasound stimulation

real TUS group

Experimental group

Description:

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.

Treatment:

Device: real transcranial ultrasound stimulation