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Transcutaneous Spinal Cord Stimulation and Robotic Therapy

NCT05210166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-05-12

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

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.

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.

Sponsors & Collaborators

  • Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion

    collaborator OTHER

  • University of Castilla-La Mancha

    lead OTHER

Principal Investigators

  • Julio Gómez-Soriano, PhD · Castilla La Mancha University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-04-10
Completion
2023-04-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210166 on ClinicalTrials.gov