NCT07154199

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Brain Fog
• Long COVID
• Transcranial Ultrasound Stimulation

Interventions

Type	Name	Description
DEVICE	sham 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.
DEVICE	real 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

Timeline

• Start date: 2023-01-06
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

2 sites across 1 country: China