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

NCT07289191 | Recruiting

• 1 other identifier: 2.022.386
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 6MWT

  6 METER WALKING TEST

  Baseline, after 3 weeks, and 1 week follow-up

Secondary Outcomes (2)

• MVC

  Baseline, after 3 weeks, and 1 week follow-up

• Hmax\Max ratio

  Baseline, after 3 weeks, and 1 week follow-up

Study Arms (2)

multisegmental tSCS combined with gait rehabilitation

EXPERIMENTAL

Device: transcutaneous spinal cord stimulation

Gait rehabilitation

OTHER

baseline, during transcutaneous spinal cord stimulation (tSCS) at C5, L1, Coc1, or combinations of two segments or multisegment stimulation, and the final assessment.

Device: transcutaneous spinal cord stimulation

Interventions

transcutaneous spinal cord stimulation DEVICE

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.

Gait rehabilitation; multisegmental tSCS combined with gait rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Guttmann: lead

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: December 17, 2025
• Study Start: January 1, 2021
• Primary Completion: September 11, 2024
• Study Completion: February 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)