Limb motor dysfunction after brain injury
Conditions
Interventions
Test group:Spinal Cord Electrical Stimulation Synchronized with Artificial Exoskeleton
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The patient has suffered from brain injury for at least 6 months, accompanied by limb motor dysfunction; (2) The patient's age is between 18 and 70 years old (inclusive); (3) The patient and their family members have a strong willingness to undergo stimulator implantation; (4) The patient has a certain ability to understand and communicate, voluntarily participates in the study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of persistent dyspnea; (2) Presence of language or cognitive impairment; (3) Severe depression (Beck Depression Inventory score >= 16); (4) Current progressive brain disease; (5) Presence of surgical contraindications (e.g., history of adverse reactions to anesthetics, deemed unsuitable for surgery by the surgeon, etc.); (6) Having other implanted stimulation devices in the body (such as cardiac pacemakers or other neurostimulators), or using other investigational devices or drugs; (7) Requirement for thermotherapy currently or during the trial period; (8) Presence of significant joint deformities; (9) Pregnant or lactating women, or patients who cannot take appropriate contraceptive measures during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the FMA-UE (Fugl-Meyer Assessment for Upper Extremity) motor function score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in motor function as measured by the FMA-UE (Fugl-Meyer Assessment for Upper Extremity) score ;The change in the Modified Ashworth Scale (MAS) for spasticity assessment ;The changes in somatosensory evoked potentials (SSEPs) of the upper and lower limbs ;The changes in motor evoked potentials (MEPs) of the upper and lower limbs ;The changes in electromyography (EMG) tests of the upper and lower limbs ;The changes in electroencephalogram (EEG) tests ; | — |
Countries
China
Contacts
Public ContactWenling Li
The Second Hospital of Hebei Medical University
Outcome results
None listed