Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combin… (NCT06957340) | Clinical Trial Compass
CompletedNot Applicable
Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
China30 participantsStarted 2023-01-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. First-time stroke patients diagnosed with ischemic stroke via imaging techniques such as CT or MRI;
. Duration of the disease between 15 days and 6 months, with stable condition;Age between 18 and 75 years;
. Patients without severe intellectual, language comprehension, or behavioral impairments, capable of completing scale assessments, with an MMSE score of ≥24;
. Hemiplegia on one side and at least a 3rd-level seated balance, with Brunnstrom stage II or higher for the upper limb，able to perform movements with the assistance of the upper limb virtual reality training；
. No use of antidepressant medications in the past month, with PHQ-9 score≥10 and HAMA score≥17；
. Patients who are aware of the study details and have signed the informed consent form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined transcranial ultrasound stimulation with virtual reality arm exercises to treat depression after stroke — is there anything from the results of this completed study that might be relevant to my own situation?
2The trial measured both motor function with the WMFT and depression scores with the PHQ-9 and HAMD — does that suggest my doctor would need to address both my physical recovery and my mood together, and is that something my current treatment plan is already doing?
3Since this study is listed as Phase NA, meaning it was likely an early observational or feasibility study, how much confidence can we have in the safety and effectiveness of these two therapies combined, versus more established treatments for post-stroke depression?
4Low-intensity transcranial ultrasound stimulation is not a common treatment — is it available at this facility or anywhere nearby, and would my doctor consider it appropriate to explore for someone in my situation?
5Given that this trial has already been completed, is there any way to access the published results or ask whether standard care options like antidepressants or conventional physical therapy might work just as well for post-stroke depression before considering a newer approach like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
WMFT
Timeframe: From enrollment to the end of treatment at 4 weeks
2
PHQ-9
Timeframe: From enrollment to the end of treatment at 4 weeks
3
HAMD
Timeframe: From enrollment to the end of treatment at 4 weeks
. Patients with metallic implants in the cranium or those with a pacemaker;
. Patients with unstable conditions, multiple brain infarctions, severe heart disease, or other significant organ conditions and complications, or a history of cancer.