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Spinal Cord Injuriestscs_LokomatNCT05210166

Transcutaneous Spinal Cord Stimulation and Robotic Therapy

A study testing Active tSCS and Lokomat in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Active tSCS and Lokomat
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteSpain
Study dates
1 Mar 2021to 10 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Metal implants over T11-T12
  • Electronic device implants.
  • Epilepsy
  • Allergy to the electrode material
  • Pregnancy
  • Concomitant pathologies
Show all 9Show fewer
  • Pathology or fracture of the lower limbs
  • Musculoskeletal injury in the lower limbs
  • Lower limbs dysmetria

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Castilla-La Mancha University

    Toledo, 45071

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Active tSCS and Lokomat, Sham tSCS and Lokomat
Keywords
Neuromodulation, Spinal cord injury, Robotics, Transcutaneous spinal cord stimulation, Lokomat
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active tSCS and LokomatDevice

    Also called Experimental

    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.

  • Sham tSCS and LokomatDevice

    Also called Controlled

    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.

Study groups in NCT05210166
Study groupRoleWhat they receive
Active tSCS and LokomatActive comparator20 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.
Receives: Device: Active tSCS and Lokomat
Sham tSCS and LokomatPlacebo comparator20 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.
Receives: Device: Sham tSCS and Lokomat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  2. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  2. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  3. Change in gait function

    10-meter walk test (10MWT) will be expressed in seconds.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  4. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  5. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  6. 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).

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  7. 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.

    Measured: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.

  8. 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".

    Measured: At follow-up at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start1 Mar 2021
  3. Primary completion10 Apr 2023
  4. Study completion10 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05210166
Sponsor's protocol ID
ExoStim Project
Acronym
tscs_Lokomat
Status last verified
Mar 2021
First submitted
12 Jan 2022
Last updated
12 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Comino-Suarez N, Moreno JC, Megia-Garcia A, Del-Ama AJ, Serrano-Munoz D, Avendano-Coy J, Gil-Agudo A, Alcobendas-Maestro M, Lopez-Lopez E, Gomez-Soriano J. Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial. J Neuroeng Rehabil. 2025 Jan 30;22(1):15. doi: 10.1186/s12984-025-01545-8.

    PubMed 39885542

Questions about this trial

What is this clinical trial studying?

A study testing Active tSCS and Lokomat in people with Spinal Cord Injuries, run by University of Castilla-La Mancha at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in isometric maximal voluntary contraction strength (time frame: Baseline, post-treatment (after 20 sessions) and follow-up at 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05210166, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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