RecruitingNot ApplicableNCT07289191

Development of a Novel Strategy to Analyze the Effect on Gait Using Transcutaneous Spinal Current Stimulation in Incomplete Spinal Cord Injured Patients

Design of tSCS Strategies to Promote Neural Plasticity and Improve Functional Outcomes During Rehabilitation of Locomotion

Sponsor

Institut Guttmann

Enrollment

10 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries Gait Disorders, Neurologic Non Invasive Spinal Stimulation Motor Function; Retardation Stimulation Charecteristic

Summary

To determine whether the combination of non-invasive spinal cord stimulation together with gait rehabilitation reduces spasticity and facilitates recovery of lower limb motor strength and gait function in patients with incomplete SCI, as well as studying the underlying physiopathological changes following incomplete SCI and its modulation by non-invasive stimulation techniques.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Male or female more than 18 years old;
With a stable traumatic o nor traumatic incomplete motor cervical or thoracic SCI;
Time since SCI more than 6 months;
American Spinal Injury Association Impairment Scale (AIS)-D who could realize gait at least 6 meters with or without technical help;
Capacity for compression the nature of the study and signed informed consent.

Exclusion Criteria5

Unstable medical condition (cancer, acute infections, etc.);
Severe spasticity (≥ 3 score on the Modified Ashworth scale (MAS)),
Peripheral nerve affectation;
Ulcers on the electrode applied area;
Intolerance of tSCS.

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Interventions

DEVICEtranscutaneous spinal cord stimulation

This study consisted of: (i) baseline condition; and (ii) tSCS conditions: which consisted of 7 different combinations applied to different segments of the spinal cord in the randomized order: C5, L1, Coc1, C5+L1, C5+Coc1, L1+Coc1, C5+L1+Coc1 and than (iii) final condition: Individuals with SCI realized all clinical assessment after the last condition of tDCSs. We included the final control condition to ensure the reliability of our findings. Baseline, tSCSs, and final control conditions were conducted as part of three assessments: the 6MWT and MVC-QM and MVC-TA, Hmax/Mmax ratio.