Persistent moderate to severe upper limb hemiplegia
Conditions
Interventions
Surgical group:DN-DBS
Sponsors
The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. confirmed diagnosis of stroke (ischemic or hemorrhagic) within 12-36 months 3. persistent moderate to severe upper limb hemiplegia, defined as Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score =1 for elbow flexion, elbow extension, or finger flexion/extension) 4. preserved standard physiological motor pathway response, evidenced by motor evoked potential (MEP) peak-to-peak amplitude >=100µV in partially contracted extensor digitorum communis or proximal muscles (including forearm or wrist flexors) 5. ability of the subject or their legal guardian to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe spasticity or contracture of upper limb muscles 2. diagnosed neurological/psychiatric disorders (e.g., Alzheimer's disease, amyotrophic lateral sclerosis [ALS], Parkinson's disease) 3. contraindications to neurosurgical procedures 4. contraindications to CT/MRI scanning (e.g., claustrophobia) 5. female subjects with known pregnancy, lactation, or positive pregnancy test prior to randomization 6. contraindications to general anesthesia (e.g., severe arrhythmia, severe anemia, abnormal hepatic/renal function) 7. life expectancy <12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Limb muscle strength and tone;Fugl-Meyer Assessment (FMA) score;Modified Ashworth Scale (MAS);somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs).;brain function; | — |
Countries
China
Contacts
Public ContactNiu Chaoshi
The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science
Outcome results
None listed