Safety and Efficacy of Epidural Spinal Cord Stimulation in Patients with Limb Paralysis After Stroke or Traumatic Brain Injury

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500103168

Enrollment

Unknown

Registered

2025-05-26

Start date

2025-05-28

Completion date

Unknown

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

intervention group:Epidural Spinal Cord Stimulation

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-80 years; 2) Ischemic stroke, hemorrhagic stroke, or traumatic brain injury causing limb paralysis occurring more than 3 months prior to enrollment, with stable vital signs and intracranial condition; 3) Presence or absence of impaired consciousness; 4) For conscious patients without significant limb muscle hypertonia: Upper limb FMA score 7, lower limb score 5; 5) For conscious patients without significant limb muscle hypertonia: Significant muscle strength reduction (not exceeding Grade 3 but >0) during movement in one or more joints of the affected limb; 6) For conscious or unconscious patients with significant limb muscle hypertonia, hyperreflexia, or muscle spasms: MAS score >= 2; 7) Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1) Receiving anticoagulant, antispasmodic, antiepileptic, or similar medications during the entire study period; 2)Patients with impaired consciousness but no significant muscle hypertonia in the paralyzed limb (flaccid paralysis); 3) Presence of any medically implanted device in the body; 4) Any contraindications to spinal cord stimulation (SCS); 5) Suspected or confirmed pregnancy; 6) Inability to perform neurological function assessments; 7) Severe terminal illness or other serious medical conditions that may impair the ability to participate in the study; 8) Severe claustrophobia; 9) Researchers deem joint contractures too severe for study participation; 10) Other circumstances where researchers determine participation is not feasible; 11) Failure to obtain informed consent.

Design outcomes

Primary

Measure	Time frame
Modified Ashworth Scale, MAS;Muscle strength;Fugl-Meyer motor function assessment, FMA;Action Research Arm Test, ARAT;Composite Spasticity Scale, CSS;Coma Recovery Scale-Revised, CRS-R;	—

Countries

China

Contacts

Public ContactYi Yang

Beijing Tiantan Hospital Affiliated to Capital Medical University

yangyi_81nk@163.com+86 138 1096 0062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026