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NCT Number: NCT07289191

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location status: Recruiting

Location contact

Hatice Kumru, PhD

CONTACT

[email protected]

0034 4970000 ext. 3633

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 6MWT

    Time frame: Baseline, after 3 weeks, and 1 week follow-up

    6 METER WALKING TEST

Secondary outcomes

  1. MVC

    Time frame: Baseline, after 3 weeks, and 1 week follow-up

    Maximum voluntary contraction

  2. Hmax\Max ratio

    Time frame: Baseline, after 3 weeks, and 1 week follow-up

Sponsors and collaborators

Lead sponsor

Institut Guttmann

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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