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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitut Guttmann

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: multisegmental tSCS combined with gait rehabilitationExperimental treatment 1 intervention
Group B: Gait rehabilitationOther 1 intervention

Trial outcomes

Primary outcomes

1

6MWT

6 METER WALKING TEST

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

Secondary outcomes

1

MVC

Maximum voluntary contraction

Time frame
Baseline, after 3 weeks, and 1 week follow-up
2

Hmax\Max ratio

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.