NCT06957340

Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Abstract: objective:To study whether post-stroke depression can be improved through low-intensity transcranial ultrasound stimulation combined with upper limb virtual reality training, explore its possible mechanisms, and provide new rehabilitation strategies for further treatment of post-stroke depression patients. Methods:30 patients with PSD were selected as the subjects, and randomly divided into sham control group and combination treatment group according to computer randomization. Each group was 15 cases. The combined treatment group was subjected to LITUS, virtual reality upper limb training, routine medication and rehabilitation treatment. The control group only conducted virtual upper limb training, routine medication and rehabilitation treatment, and TUS was a false stimulation treatment. Keywords:Ultrasoun,transcranial,ultrasound,stimulation,virtual reality,stroke,post-stroke depression

Detailed description

Abbreviation：Transcranial Ultrasound Stimulation(TUS),low intensity focused ultrasound (LIFU),low intensity transcranial Ultrasound stimulation(LITUS),virtual reality(VR),post-stroke depression(PSD),Wolf Motor Function Test(WFMT),Patient Health Questionnaire-9(PSQ-9),Hamilton Depression Scale(HAMD),Pittsburgh sleep quality index(PSQI)

Conditions

• Post Stroke Depression
• Stroke

Interventions

Type	Name	Description
DEVICE	Low-Intensity Transcranial Ultrasound Stimulation	LITUS is conducted using the UE880C model from RuAo Medical Technology Co., Ltd. (Beijing). The parameters are set as follows:Frequency: 800(1+10%) kHz,Pulse repetition period: 25 ms,Duty cycle: 50%,Output power: 1.2 W,Maximum output power duration: 0.6 W,Effective sound intensity: 0.4 W/cm².During treatment, the patient is placed in a quiet room and asked to relax in a seated position. Three ultrasound probes are coated with a coupling agent and positioned on the patient's forehead.The total treatment duration is 20 minutes. The upper limb rehabilitation virtual training is used by the EM-BURT02-01 model from Eston.The affected limb is fixed to the robotic arm. Each treatment session consists of two virtual games (such as "Airplane Battle," "Mosquito Smasher," and other motion-based games).Each game lasts for 10 minutes, totaling 20 minutes of treatment. Treatment is administered 5 times a week.
DEVICE	sham TUS	In the sham group, the machine only operates for 30 seconds, then stopping. Due to the physical characteristics of ultrasound, this stimulation cannot be perceived.Treatment is administered 5 times a week.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

1 site across 1 country: China