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 range18 Years – 75 Years

SexALL

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.

Exclusion criteria

✕. 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.

What they're measuring

WMFT

Timeframe: From enrollment to the end of treatment at 4 weeks

PHQ-9

Timeframe: From enrollment to the end of treatment at 4 weeks

HAMD

Timeframe: From enrollment to the end of treatment at 4 weeks

Trial details

NCT IDNCT06957340

SponsorAnhui Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-31

View on ClinicalTrials.gov More Post Stroke Depression trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

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.

Exclusion criteria

✕. 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.