Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia

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Brief Title

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

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.
    



Study Type

Interventional


Primary Outcome

The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point

Secondary Outcome

 The change of nociception improvement: ASIA pin-prick sensory score

Condition

Chronic Paraplegia

Intervention

Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol

Study Arms / Comparison Groups

 WANR protocol
Description:  Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

August 1, 2019

Completion Date

December 31, 2020

Primary Completion Date

March 31, 2020

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.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Guo-Guang Zhao, M.D., 00861083198252, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03992690

Organization ID

XW-[2019]-023


Responsible Party

Sponsor

Study Sponsor

Xuanwu Hospital, Beijing

Collaborators

 the Alberto Santos Dumont Association for Research Support

Study Sponsor

Guo-Guang Zhao, M.D., Principal Investigator, Xuanwu Hospital, Beijing


Verification Date

June 2019