Skip to content

Clinical trial of the safety, efficacy and feasibility of implantable spinal cord neurostimulator system for the treatment of limb motor dysfunction after stroke

Clinical trial of the safety, efficacy and feasibility of implantable spinal cord neurostimulator system for the treatment of limb motor dysfunction after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089894
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-09-23
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Limb paralysis after stroke

Interventions

Treatment group:Implant spinal cord neurostimulator for treatment of paralysis after stroke

Sponsors

Changzhou No.2 People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Stroke greater than or equal to 6 months; (2) Age = 18 years old and = 70 years old; (3) During the test period, the motor function was significantly improved, and the subjects and their families had a strong desire to permanently implant the stimulator; (4) The subject has a certain ability to understand and express, voluntarily participates and signs the informed consent form

Exclusion criteria

Exclusion criteria: (1) the presence of persistent dyspnea; (2) the presence of language or cognitive impairment; (3) severe depression (Beck Depression Rating Scale= 16 points); (4) Current progressive brain disease; (5) Presence of contraindications to surgical procedures (e.g., history of adverse reactions to anesthetics, considered unsuitable for surgery by the surgeon, etc.); (6) Other stimulation devices such as pacemakers or other nerve stimulators are being used in the body, or other experimental devices or drugs are being used; (7) There is a requirement for hyperthermia treatment at present or during the trial;

Design outcomes

Primary

MeasureTime frame
The change in Fugl-Meyer Assessment at 90 days after surgery compared with baseline;

Secondary

MeasureTime frame
The change in Fugl-Meyer Assessment at 180 days after surgery compared with baseline;The change in Modified Ashworth Scale at 90 and 180 days after surgery compared with baseline;The change in sensory evoked potentials in upper and lower limbs aompared with bast 90 and 180 days after surgery celine;The change in motor evoked potentials in upper and lower limbs at 90 and 180 days after surgery compared with baseline;The change in MEG at 90 and 180 days after surgery compared with baseline;The change in EEG at 90 and 180 days after surgery compared with baseline;

Countries

China

Contacts

Public ContactLiu fang

Changzhou No.2 People’s Hospital

doctorliu411@163.com+86 180 6856 2999

Outcome results

None listed

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