💬In plain words
What the trial is, and whether it could suit you
Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face a life in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment options exist. One of the most plastic systems involved in locomotion is the pontomedullary reticulospinal tract, which is the oldest locomotor command system existing in most vertebrates, including primates. Muscle activation patterns for limb movements are programmed in the spinal cord and have to be activated and coordinated through commands from the so called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower mesencephalic tegmentum sending uni- and bilateral signals through the medullary reticulospinal tracts. Classical physiological studies showed that electrical stimulation of th
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Informed Consent
2. Participation in two assessment sessions before enrollment (Screening and baseline)
3. Willingness and ability to comply with the protocol and to attend required study training and visits
4. Male or female subjects
5. Age 18-75
6. Motor incomplete SCI
7. Level of lesion: T10 and above, based on AIS level, preservation of sacral function
8. Focal spinal cord disorder caused by either trauma or non-traumatic and non-progressive condition (like hemorrhage, benign tumor)
9. Minimum 3 months of recovery after SCI
10. Completed in-patient rehabilitation program
11. WISCI II, level \>2 (0-20 items): assistance of one or more persons. Ability to walk at least 10 meters
12. Stable medical and physical condition.
13. Adequate care-giver support and access to appropriate medical care in patient's home community
Exclusion Criteria:
1. Enrollment of the investigator, his/her family members, employees and other dependent persons
2. Limitation of standing and walking function based on accompanying (CNS) disorders
3. Cardiovascular disorders restricting physical training or peripheral nerve disorders
4. Implanted technical devices (pacemaker, defibrillator)
5. History of significant autonomic dysreflexia
6. Cognitive disorders/brain damage
7. Drug refractory epilepsy
8. Severe joint contractures disabling or restricting lower limb movements
9. Haematological disorders with increased risk of bleeding during surgical interventions
10. Participation in another study with investigational drug within the 30 days preceding and during the present study
11. Congenital or acquired lower limb abnormalities (affection of joints and bone)
12. Women who are pregnant or breast feeding or planning a pregnancy during the course of the study
13. Lack of safe contraception
14. Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological problems, dementia etc.
15. Known or suspected non-compliance, drug or alcohol abuse
16. Current or prior malignancy
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