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Tests a remote limb treatment to prevent depression after stroke

Tests remote ischemic conditioning, a device-based treatment, in adults at risk of post-stroke depression.

Key facts

Who runs it
Xuanwu Hospital, Beijing
Where
Baoding, Beijing, Jilin City, Jincheng, and Tongren, ChinaSee the 5 sites
Trial code
Registry title
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression
Status
Not yet recruiting
People taking part
240 people, planned
Started
10 Apr 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • RIC
  • Sham-RIC
Record updated
10 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a recent acute ischemic stroke who start treatment within 48 hours. It tests whether limb cuff treatment (remote ischemic conditioning) helps prevent depression after stroke.

Age
18 years or older
Sex
Women and men can both join
Disease stage
Acute ischemic stroke, treatment within 48 hours of onset, NIHSS score from 6 to 25, mRS of 1 or less before the stroke

Main reasons for not taking part

  • Baseline HAMD-24 score of 8 or more
  • History of severe mental illness such as depression, bipolar disorder or schizophrenia
  • Cognitive impairment, disturbance of consciousness, severe hearing impairment or aphasia that prevents taking part in the assessments
  • Pregnant or breastfeeding women, or a positive pregnancy test
  • Taking part in another clinical trial within three months

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Patient age≥18 years
  • No gender preference
  • Diagnosed with acute ischemic stroke
  • From onset to treatment ≤48 h
  • 6≤ NIHSS scores ≤25
  • Premorbid mRS ≤1
  • Signed informed consent

Who cannot take part

  • Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, etc
  • A history of severe mental illness such as depression, bipolar disorder, and schizophrenia
  • A history of mental disorders caused by other organic diseases, such as post-Parkinson depression
  • Participants with cognitive impairment, disturbance of consciousness, severe hearing impairment, or aphasia who were unable to cooperate with the assessment
  • A history of autoimmune diseases (such as multiple sclerosis, neuromyelitis optica spectrum disorders, systemic lupus erythematosus, etc.), malignant tumors, or obstructive sleep apnea hypopnea syndrome
  • Uncontrolled severe hypertension (systolic pressure >180mmHg or diastolic pressure >110 mmHg after drug treatment)
  • Subclavian artery stenosis≥50% or subclavian steal syndrome
  • Severe coagulation dysfunction, platelet count < 100×10\^9/L, cardiac dysfunction (NYHA class Ⅲ or above), hepatic dysfunction (aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal), or renal dysfunction (serum creatinine > 265μmol/L)
  • Baseline HAMD-24 scores ≥8
  • Infarction area overlapped with the area where the DTI-ALPS index is calculated
  • Intracranial tumor, arteriovenous malformation, or aneurysm
  • Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc
  • Women known to be pregnant or lactating, or have a positive pregnancy test
  • Participating in other clinical trials within three months
  • Participants not suitable for this clinical studies considered by researcher

Where in China

  • Baoding People's HospitalBaoding, ChinaContact: Lan HouNo longer taking part
  • Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Lina JiaNo longer taking part
  • Jilin People's HospitalJilin City, ChinaContact: Zhifei WangNo longer taking part
  • Jincheng People's HospitalJincheng, ChinaContact: Lina XuNo longer taking part
  • Tongren City People's HospitalTongren, ChinaContact: Long LiaoNo longer taking part

About the trial

What the trial wants to find out

Post-stroke depression (PSD) is characterized primarily by low mood and loss of interest following a stroke. It is one of the most common and serious complications of stroke, with an incidence of 11% to 41% within two years post-stroke. PSD significantly impacts stroke prognosis, not only hindering neurological recovery but also increasing clinical disability and mortality rates, thereby imposing substantial economic and psychological burdens on families and society. Therefore, preventing PSD is crucial for stroke rehabilitation.

Read full original descriptionShow less

Clinical trials have demonstrated that preventive antidepressant treatment can reduce PSD incidence and improve clinical outcomes; however, controversies remain regarding the timing, methods, and safety. Meanwhile, preventive psychological therapy faces challenges in implementation due to effectiveness, accessibility, and cost-effectiveness.

Remote ischemic preconditioning (RIC) is a non-invasive, cost-effective, and non-pharmacological intervention. By modulating small molecules in the peripheral and central nervous systems through transient, periodic limb blood flow restriction and reperfusion, RIC reverses neurobiological changes and demonstrates neuroprotective potential in various neurological diseases. Recently, a study showed that RIC is safe and effective in preventing PSD; however, the sample size is small and the specific mechanisms remain unclear. Therefore, this study aims to further explore the role and mechanisms of RIC in PSD prevention.

The 2 groups in the trial

  • RIC groupTreatment being tested

    Subjects in the RIC group receive standard therapy and RIC treatment.

    Treatment: RIC

  • Sham-RIC groupSham treatment, for comparison

    Subjects in the Sham-RIC group receive standard therapy and Sham-RIC treatment.

    Treatment: Sham-RIC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial
Plain-language title
Tests a remote limb treatment to prevent depression after strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 April 2025