Status:
COMPLETED
Regain of Arm and Hand Movements in Cervical Spinal Stimulation
Lead Sponsor:
Institut Guttmann
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
We will develop a "bottom to top" approach employing animal models and human testing to determine whether or not non-invasive neuro-modulation of the cervical spinal cord concomitant with upper limb r...
Detailed Description
Patient selection criteria: The study will consist of two populations of patients: Population A will include a total of 10-15 patients with an incomplete cervical lesion (ASIA C and D), and a populati...
Eligibility Criteria
Inclusion
- male or female, more than 18 years old;
- a stable traumatic or no traumatic cervical SCI
- time since SCI: 3-12 months
- AIS A, B, C, and D with but at least ≥ 2 muscles affected in the upper extremities, with a total sum of muscle strength more than 2 points in two muscles (the wrist extension together with abductor pollicis brevis (APB) at least in one side).
Exclusion
- unstable medical condition (cancer, acute infections, etc.)
- dependent on mechanical ventilation
- severe spasticity (≥3 score on the Modified Ashworth scale-MAS)
- contraindication for rehabilitation assisted with a robotic exoskeleton (Armeo®Power)
- peripheral nerve injury
- intolerance of tSCS, peacemakers, electronic implants, or episodes of epilepsy
- participating in another investigation.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07140354
Start Date
September 1 2020
End Date
September 8 2024
Last Update
August 24 2025
Active Locations (1)
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1
Institut Guttmann
Badalona, Barcelona, Spain, 08916