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Clinical trial to evaluate the safety, efficacy, and feasibility of the implantable spinal cord neurostimulator system in the treatment of limb motor dysfunction following brain injury.

Clinical trial to evaluate the safety, efficacy, and feasibility of the implantable spinal cord neurostimulator system in the treatment of limb motor dysfunction following brain injury.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101046
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Hemiplegia

Interventions

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18-75 years old (including boundary value); Unilateral limb paralysis due to clinical diagnosis of stroke, traumatic brain injury or brain tumor (course of >=6 months); Fugl-Meyer Upper Extremity Motor Function Score (FMA-UE) <=40 points; Modified Ashworth Spasm Score (MAS) <=3; Sign the informed consent form, voluntarily participate in the study and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: Absolute exclusions: (1) Presence of spinal cord injury or peripheral neuropathy; (2) Skin infection or systemic active infection at the implantation site; (3) Severe cardiopulmonary insufficiency (NYHA cardiac function class>=grade III or FEV11.5 or platelet <80×10?/L)¹; (5) Pregnant or lactating females. Relative exclusions: (1) cognitive dysfunction (MMSE score< 24 points); (2) Previous spinal cord or deep brain stimulation surgery; (3) Combined with other neurodegenerative diseases (such as Parkinson's disease, ALS, etc.); (4) Other conditions judged by the investigator to be inappropriate for participation.

Design outcomes

Primary

MeasureTime frame
FMA-UE (Fugl-Meyer) motor function score;

Secondary

MeasureTime frame
FMA-UE (Fugl-Meyer) motor function score;Spasm Rating Scale (modified Ashworth method);Somatosensory Evoked Potentials of Upper and Lower Limbs;Motor-evoked Potentials of Upper and Lower Limbs;Electromyography Test;Electroencephalogram;

Countries

China

Contacts

Public ContactChongjie Cheng

The First Affiliated Hospital of Chongqing Medical University

358187887@qq.com+86 153 3458 7556

Outcome results

None listed

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