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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Gait Disorders, Neurologic; Motor Function; Retardation; Non Invasive Spinal Stimulation; Stimulation Charecteristic
• Intervention / Treatment: Device: transcutaneous spinal cord stimulation

Detailed Description

Methodology: This task will involve the clinical and functional assessment of patients completing gait training with and without tSCS as defined in T4.2 to demonstrate the effects of tSCS and define the most favorable parameters. During this task, the assessments that will be completed will be defined by IG and then carried out according to the methodology that is set and agreed upon. Assessments will need to evaluate several factors:

• The American Spinal Cord Injury Association Impairment Scale (ASIA) and the International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI)38 will be used to determine level and severity of SCI and to evaluate sensory and motor deficit.
• For gait outcome measures, 10 meters walking test (10MWT) and Walking Index for SCI (WISCI) II will be assessed.
• For spasticity evaluation, Modified Ashworth modified score (MAS) will be used.
• Neurophysiological studies may be included to study: 1) spinal cord excitability using F and H wave, 2) corticospinal conduction using transcraneal magnetic stimulation for MEP recording, and 3) muscle activity using surface EMG recording of lower limb muscles.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut Guttmann
      • Contact: Hatice Kumru, PhD; Phone Number: 3633 0034 4970000; Email: hkumru@guttmann.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multisegmental tSCS combined with gait rehabilitation	Device: transcutaneous 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.
Other: Gait rehabilitation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	6 METER WALKING TEST	Baseline, after 3 weeks, and 1 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MVC	Maximum voluntary contraction	Baseline, after 3 weeks, and 1 week follow-up
Hmax\Max ratio		Baseline, after 3 weeks, and 1 week follow-up

Collaborators and Investigators

• Sponsor: Institut Guttmann

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 11, 2024
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 21, 2024
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Gait Disorders, Neurologic
• Other Study ID Numbers: 2.022.386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No