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NCT07874269
MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
Conditions: Ischemic Stroke
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 205
Sponsor: Jumraini Tammasse
Location: Inggit Medical Centre Makassar South Sulawesi
Summary
This randomized, double-blind, controlled clinical trial evaluates the effectiveness and safety of combined mesenchymal stem cell (MSC) secretome and repetitive transcranial magnetic stimulation (rTMS) for motor recovery in patients with subacute ischemic stroke. Participants will be randomized to either an intervention group receiving intravenous MSC secretome combined with high-frequency ipsilesional rTMS or a control group receiving placebo infusion and sham rTMS. The intervention is administered once weekly for 8 weeks. The primary outcome is change in motor function measured using the Fugl-Meyer Motor Scale. Secondary outcomes include changes in quantitative electroencephalography biomarkers, including sensorimotor rhythm, delta-theta-to-alpha-beta ratio, and beta coherence, as well as spasticity assessed using the Modified Ashworth Scale and treatment-related adverse events.
Eligibility Criteria
Inclusion Criteria:
1. Age 30 to 75 years.
2. Diagnosis of subacute ischemic stroke, 1 to 6 months after stroke onset.
3. First-ever ischemic stroke.
4. Ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).
5. Able to undergo repetitive transcranial magnetic stimulation (rTMS) therapy.
Exclusion Criteria:
1. History of active seizures.
2. Presence of intracranial metal or implanted devices that are contraindications to rTMS.
3. Severe systemic disease that may affect participant safety or interfere with study participation.
Source: ClinicalTrials.gov (NCT07874269). StuddyBuddy aggregates publicly available trial information.