Clinical trial NCT05210166: Transcutaneous Spinal Cord Stimulation and Robotic Therapy
Official title: Transcutaneous Spinal Cord Stimulation Combined With Robot-assisted Therapy in Incomplete Spinal Cord Injury Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Neuromodulation
Spinal cord injury
Robotics
Transcutaneous spinal cord stimulation
Lokomat
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
First posted: 2022-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a double-blind, randomized, controlled clinical trial.

There will be two groups:

Group A (n=15): tSCS combined with Lokomat Group B (n=15): Sham-tSCS combined with Lokomat
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in isometric maximal voluntary contraction strength
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in lower limbs muscle strength (LEMS)
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Secondary outcomes:
measure: Change in lower limbs spasticity
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in peak-to-peak amplitude and latency of motor evoked potentials
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in gait function
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in balance and fall risk
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in aerobic capacity and endurance
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in walking ability
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Change in daily function
timeFrame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
measure: Blinding assesment
timeFrame: At follow-up at 4 weeks.
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Castilla-La Mancha University
Study officials:
affiliation: Castilla La Mancha University
name: Julio Gómez-Soriano, PhD
role: STUDY_DIRECTOR
References: