Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- WMFT
研究概览
简要总结
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
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were as follows:
- •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.
排除标准
- •The exclusion criteria were as follows:
- •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.
研究组 & 干预措施
sham TUS group
The sham group only underwent upper limb virtual reality training, with LITUS serving as a placebo.
干预措施: sham TUS (Device)
TUS group
Low-Intensity Transcranial Ultrasound Stimulation combined with Upper Limb Virtual Reality Training
干预措施: Low-Intensity Transcranial Ultrasound Stimulation (Device)
结局指标
主要结局
WMFT
时间窗: From enrollment to the end of treatment at 4 weeks
Wolf Motor Function Score: The Wolf Motor Function Test (WMFT) is the internationally preferred scale widely used to assess the effectiveness of rehabilitation training in improving upper limb function. It consists of 15 assessment items, many of which involve upper limb movements commonly used in daily life, such as placing the forearm on a table, grip strength, and fine motor skills. Each item is scored on a 6-point scale ranging from 0 to 5 based on the patient's functional performance, with higher scores indicating better function. The total score is 75. This assessment method is simple, easy to administer, does not easily fatigue the patient, and is particularly suitable for evaluating hand and upper limb functional recovery in stroke patients.
PHQ-9
时间窗: From enrollment to the end of treatment at 4 weeks
PHQ-9 (Patient Health Questionnaire-9): The PHQ-9 is a commonly used screening tool for depression. It is based on the nine diagnostic criteria from the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, developed by the American Psychiatric Association). The scale is used to assess whether an individual has depression and to determine the severity of the condition. It has good reliability and validity, and its assessment is simple, quick, and well-accepted by patients. The total score is 27, with higher scores indicating greater severity of depression.
HAMD
时间窗: From enrollment to the end of treatment at 4 weeks
The Hamilton Depression Rating Scale (HAMD) is one of the most widely used scales in clinical settings for assessing depressive states. Based on its assessment content, it has three versions; the HAMD-24 version is used here. This version includes multiple indicators such as mood, somatic symptoms, and sleep, allowing for an effective evaluation of the patient's functional improvement.
次要结局
- PSQI(From enrollment to the end of treatment at 4 weeks)
- BDNF and 5-HT(From enrollment to the end of treatment at 4 weeks)
研究者
Mingyan Zhuang
Principal Investigator
Anhui Medical University