Transcutaneous Spinal Cord Stimulation and Robotic Therapy (tscs_Lokomat)

University of Castilla-La Mancha

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Active tSCS and Lokomat; Device: Sham tSCS and Lokomat

Study type: Interventional

Funder types: Other

Identifiers

NCT05210166

ExoStim Project

Details and patient eligibility

About

Lumbosacral spinal stimulation activates the neural network involved in the control of locomotion at the spinal level. However, its effects are limited to the production of robust rhythmic patterns of alternating movement, being currently in the absence of therapeutic value. On the other hand, the use of robotic technology for gait rehabilitation has experienced significant growth during the last years and its clinical efficacy is similar to others traditional interventions.

Full description

Spinal cord injury (SCI) often results in complete or partial paralysis below the level of lesion, having a profound physical, psychological and socioeconomic impact on the affected person's life. Between the different approaches for the rehabilitation of SCI, we can find robot therapy. Robot-assisted gait training has emerged as a promising therapy for improving walking ability, balance and motor function in neurological patients. The underlying principle of this therapy is based on the execution of repetitive and task-specific training able to generate appropriate afferent inputs, activating the central pattern generators in the lumbosacral spinal cord. Another novel therapy is the use of transcutaneous spinal cord stimulation (tSCS), applied through self-adhesive electrodes in the skin. tSCS activates similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor circuits in SCI patients. It allows the activation of rhythmic, flexo-extension movements in the paralyzed lower limbs.

The aim of this study is to analyze the feasibility, safety and efectiveness of a program of 20 sessions of 30 Hz-tSCS applied over T11-12 intervertebral space combined with Lokomat training in patients with incomplete SCI.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AIS C or D.
• 2-6 months after injury.
• Neurological level of injury between C4-T11.
• Ashworth less or equal 2.
• Penn less or equal 2.
• To understand and to sign the informed consent.

Exclusion criteria

• Metal implants over T11-T12
• Electronic device implants.
• Epilepsy
• Allergy to the electrode material
• Pregnancy
• Concomitant pathologies
• Pathology or fracture of the lower limbs
• Musculoskeletal injury in the lower limbs
• Lower limbs dysmetria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

Active tSCS and Lokomat

Active Comparator group

Description:

20 sessions, 5 sessions per week of active transcutaneous spinal cord stimulation (tSCS) combined with Lokomat will be performed. The duration of Lokomat will be 30 minutes, of which the first 20 minutes tSCS will be applied at the beginning of each session.

Treatment:

Device: Active tSCS and Lokomat

Sham tSCS and Lokomat

Placebo Comparator group

Description:

20 sessions, 5 sessions per week of sham transcutaneous spinal cord stimulation (sham-tSCS) combined with Lokomat will be performed. The duration of Lokomat will be 30 minutes, of which the first 20 minutes sham-tSCS will be applied at the beginning of each session.

Treatment:

Device: Sham tSCS and Lokomat