NCT05210166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

May 12, 2023

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

January 12, 2022

Last Update Submit

May 11, 2023

Conditions

Spinal Cord Injuries

Keywords

NeuromodulationSpinal cord injuryRoboticsTranscutaneous spinal cord stimulationLokomat

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Change in lower limbs 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

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

  • Change in gait function

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

  • Change in balance and fall risk

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

  • Change in aerobic capacity and endurance

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

  • +3 more secondary outcomes

Study Arms (2)

Active tSCS and Lokomat

ACTIVE COMPARATOR

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

Sham tSCS and Lokomat

PLACEBO COMPARATOR

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

Interventions

Active tSCS and LokomatDEVICE

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.

Also known as: Experimental
Active tSCS and Lokomat
Sham tSCS and LokomatDEVICE

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.

Also known as: Controlled
Sham tSCS and Lokomat

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AIS C or D.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Castilla-La Mancha University

Toledo, 45071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 39885542DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Julio Gómez-Soriano, PhD

    Castilla La Mancha University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
For blinding of participants: The protocol will be the same in the active tSCS and sham tSCS groups. The sham stimulation will consist of the same stimulation parameters used for active tSCS, except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 s and then slowly decreased to zero. The participants will receive the same instructions that given to the active tSCS session. For blinding of outcomes assessor: Two blinded assessors will perform the evaluations before, after and a follow-up at 4 weeks post-intervention. The operator of the Lokomat will be also masked to the group allocation. To ensure this, the same stimulator and electrode location will be used for both groups and the screen of the device will be covered. Only the investigator who applies spinal stimulation will know which group belongs the patient.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 27, 2022

Study Start

March 1, 2021

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

May 12, 2023

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)