Transcutaneous Spinal Cord Stimulation and Robotic Therapy (tscs_Lokomat)

Transcutaneous Spinal Cord Stimulation Combined With Robot-assisted Therapy in Incomplete Spinal Cord Injury Patients.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Active tSCS and Lokomat; Device: Sham tSCS and Lokomat

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Castilla-La Mancha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tSCS and Lokomat; 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.	Device: Active tSCS and Lokomat; A symmetrical biphasic 30 Hz current of 1 ms pulse-width with an electro-stimulator will be applied. For the stimulation intensity, the maximum intensity tolerated by the patient will be selected. The intensity will be increased in case of habituation to the current.; Other Names: Experimental
Placebo Comparator: Sham tSCS and Lokomat; 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.	Device: Sham tSCS and Lokomat; The protocol and device of sham tSCS combined with Lokomat will be the same as active tSCS except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 seconds and then slowly will be decreased to zero, being this intensity maintained for the remaining 20 minutes of stimulation.; Other Names: Controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in isometric maximal voluntary contraction strength	Isometric Maximal Voluntary Contraction Strength of quadriceps and tibialis anterior will be measured by hand-held dynamometer Micro Fet 2TM (Hoggan Scientific, LLC, Utah, USA) and will be expressed in Kgs.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in lower limbs muscle strength (LEMS)	Lower limb muscle strength will be measured by Lower Extremity Motor Score (LEMS). The scores vary from 0-5 for each of five key muscles of the right and left lower limbs, with a maximum score of 50 for both lower extremities.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lower limbs spasticity	Spasticity will be measured by the modified Ashworth scale (MAS). Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in peak-to-peak amplitude and latency of motor evoked potentials	Motor evoked potentials (MEP) will be elicited by transcranial magnetic stimulation (TMS, Magstim Rapid) using a double-cone coil. The optimal stimulation site will be identified for the anterior rectus and tibialis anterior muscles individually with reference to the standard CZ point. MEP threshold will be defined as the minimal TMS intensity required to evoke a motor response (>0.1 mV peak-to-peak amplitude) during slight tonic contraction of the target muscle (approximately 20% of the isometric MVC). Test MEPs during the protocol will be recorded during 20% MVC as an average of in response to 10 single-pulse stimuli that will be applied at 120% of the MEP threshold.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in gait function	10-meter walk test (10MWT) will be expressed in seconds.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in balance and fall risk	Test timed up and go (TUG) will be expressed in seconds. ≥12 seconds to complete the TUG means a higher risk for falling.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in aerobic capacity and endurance	The six-minute walk test will be expressed in meters. An increase in the distance walked indicates improvement in basic mobility.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in walking ability	Walking Index for Spinal Cord Injury (WISCI-II) assess the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury (SCI).	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Change in daily function	The Spinal Cord Independence Measure (SCIM-III) is a scale for the assessment of achievements of the daily function of patients with spinal cord injury (SCI). The third version (SCIM III) contains 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.	Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.
Blinding assesment	The success of participant and assessor blinding will be evaluated through a questionnaire after each intervention (active-tSCS and sham-tSCS) with five questions: (1) "Strongly believe the applied intervention is new treatment"; (2) "Somewhat believe the applied intervention is new treatment"; (3) "Somewhat believe the applied intervention is a placebo", (4) "Strongly believe the applied intervention is a placebo", or (5) "Do not know".	At follow-up at 4 weeks.

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion
• Investigators: Study Director: Julio Gómez-Soriano, PhD, Castilla La Mancha University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Neuromodulation; Robotics; Spinal cord injury; Lokomat; Transcutaneous spinal cord stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Trans-sodium crocetinate
• Other Study ID Numbers: ExoStim Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No