Clinical trial NCT03992690: Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
Official title: Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Paraplegia
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: the Alberto Santos Dumont Association for Research Support
First posted: 2019-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.


Eligibility criteria: Inclusion Criteria:

* 1. Discomplete spinal cord injury;
* 2. Traumatic etiology;
* 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
* 4. The level of SCI in T9-T12;
* 5. ≥12 months post injury;
* 6. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
* 7. Emotional stability;

Exclusion Criteria:

* 1. Absence of SCI, or presence of multi-segmental injury;
* 2. SCI non-traumatic etiology;
* 3. Age\<18 years or Age\>60 years;
* 4. Emotional instability;
* 5. Unavailable time to join the protocol activities;
* 6. Already enrolled in other research protocol;
* 7. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
* 8. Alcohol/drugs abuse and dependence;
* 9. Psychiatric disorders (exception: treated depression);
* 10.Cognitive deficit; visual deficit; auditory deficit;
* 11. Incapacitating pain;
* 12. Pregnancy;
* 13. Presence of limb amputations (exception: hand distal phalanges);
* 14. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
* 15. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
* 16. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
* 17. Movement disorders(e.g. ataxia);
* 18. Use of medication that can negatively impact on neurological/motor recovery;
* 19. Presence of joint deformities, presence of fractures;
* 20. Lower limb spasticity MAS (Modified Ashworth Scale)\>2;
* 21. Pressure ulcer: considering grade 3 or 4, injury size and body location;
* 22. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
* 23. Presence of cardiac or neural pacemaker;
* 24. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
* 25. Severe osteoporosis (Tscore\>-4);
* 26. Syringomyelia;
* 27. Lokomat or ZeroG training within the prior 3 months.

Primary outcomes:
measure: The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
timeFrame: After nine-months of training
Secondary outcomes:
measure: The change of nociception improvement: ASIA pin-prick sensory score
timeFrame: After nine-months of training
measure: Improvement of Walking index for SCI (WISCI)
timeFrame: After nine-months of training
measure: Change of WHO-QoL bref
timeFrame: After nine-months of training
measure: Change of post-void residual urine
timeFrame: After nine-months of training
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Guo-Guang Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: