Clinical trial NCT06957340: Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
Official title: Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Stroke Depression
Stroke
Keywords: stroke
post stroke depression
TUS
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were as follows:

  1. First-time stroke patients diagnosed with ischemic stroke via imaging techniques such as CT or MRI;
  2. Duration of the disease between 15 days and 6 months, with stable condition;Age between 18 and 75 years;
  3. Patients without severe intellectual, language comprehension, or behavioral impairments, capable of completing scale assessments, with an MMSE score of ≥24;
  4. 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；
  5. No use of antidepressant medications in the past month, with PHQ-9 score≥10 and HAMA score≥17；
  6. Patients who are aware of the study details and have signed the informed consent form.

Exclusion Criteria:

* The exclusion criteria were as follows:

  1. Patients with metallic implants in the cranium or those with a pacemaker;
  2. Patients with unstable conditions, multiple brain infarctions, severe heart disease, or other significant organ conditions and complications, or a history of cancer.

Primary outcomes:
measure: WMFT
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: PHQ-9
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: HAMD
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: PSQI
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: BDNF and 5-HT
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui medical University
state: Anhui
Study officials:
References: