Spinal Cord InjuriesNCT07289191
Development of a Novel Strategy to Analyze the Effect on Gait Using Transcutaneous Spinal Current Stimulation in Incomplete Spinal Cord Injured Patients
A study testing transcutaneous spinal cord stimulation in people with Spinal Cord Injuries and Non Invasive Spinal Stimulation, run by Institut Guttmann at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Non Invasive Spinal Stimulation, Gait Disorders, Neurologic
- What is being tested?
- transcutaneous spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Institut Guttmann
Badalona, Barcelona, 08916
Hatice Kumru, PhD, 0034 4970000 ext. 3633, hkumru@guttmann.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Non Invasive Spinal Stimulation, Gait Disorders, Neurologic, Motor Function; Retardation, Stimulation Charecteristic
- Being tested
- transcutaneous spinal cord stimulation
- Medical subject headings
- Spinal Cord Injuries, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous spinal cord stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| multisegmental tSCS combined with gait rehabilitation | Experimental | Not described Receives: 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. Receives: Device: transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
6 METER WALKING TEST
Measured: Baseline, after 3 weeks, and 1 week follow-up
Secondary outcomes (2)
MVC
Maximum voluntary contraction
Measured: Baseline, after 3 weeks, and 1 week follow-up
Hmax\Max ratio
Measured: Baseline, after 3 weeks, and 1 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jan 2021
- Primary completion11 Sep 2024
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Kumru, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289191
- Sponsor's protocol ID
- 2.022.386
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of tSCS Strategies to Promote Neural Plasticity and Improve Functional Outcomes During Rehabilitation of Locomotion
- ClinicalTrials.gov ID
- NCT07289191
- Acronym / sponsor ID
- 2.022.386
- Conditions
- Spinal Cord Injuries, Non Invasive Spinal Stimulation, Gait Disorders, Neurologic, Motor Function; Retardation, Stimulation Charecteristic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multisegmental tSCS combined with gait rehabilitation | Experimental | Device: transcutaneous spinal cord stimulation |
| Gait rehabilitation | Other | Device: transcutaneous spinal cord stimulationbaseline, during transcutaneous spinal cord stimulation (tSCS) at C5, L1, Coc1, or combinations of two segments or multisegment stimulation, and the final assessment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous spinal cord stimulationThis 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. | Device | Gait rehabilitation, multisegmental tSCS combined with gait rehabilitation |
Primary outcome
6MWT
Time frame: Baseline, after 3 weeks, and 1 week follow-up
6 METER WALKING TEST
2 secondary outcomes
MVC
Time frame: Baseline, after 3 weeks, and 1 week follow-up
Hmax\Max ratio
Time frame: Baseline, after 3 weeks, and 1 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous spinal cord stimulation in people with Spinal Cord Injuries and Non Invasive Spinal Stimulation, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (time frame: Baseline, after 3 weeks, and 1 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.