Actively Recruiting
Design of Transcutaneous Spinal Cord Stimulation Strategies to Promote Neural Plasticity and Improve Functional Outcomes During Rehabilitation of Locomotion
Led by Institut Guttmann · Updated on 2025-12-17
10
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining non-invasive spinal cord stimulation with gait rehabilitation to reduce spasticity and improve lower limb strength and walking ability in patients with incomplete spinal cord injury (SCI). The study also aims to understand the underlying physiological changes after incomplete SCI and how these may be influenced by non-invasive stimulation techniques. Participants will undergo gait training with and without transcutaneous spinal cord stimulation (tSCS) applied at various spinal segments in different combinations. The study includes baseline, stimulation, and final assessment phases, with clinical evaluations carried out after each condition. The interventions include multiple combinations of tSCS applied to spinal levels C5, L1, and Coc1, followed by gait rehabilitation. Participants will be assessed using several measures including the 6-minute walk test (6MWT), muscle strength tests, spasticity scales, and neurophysiological studies such as spinal cord excitability and muscle activity recordings. Assessments occur at baseline, after three weeks of treatment, and one week after follow-up. The study involves detailed clinical and functional evaluations to monitor changes in motor and sensory function, spasticity, and gait performance over the course of the study, which lasts for several weeks.
CONDITIONS
Brief Title
Development of a Novel Strategy to Analyze the Effect on Gait Using Transcutaneous Spinal Current Stimulation in Incomplete Spinal Cord Injured Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged more than 18 years
- Stable traumatic or non-traumatic incomplete motor cervical or thoracic spinal cord injury
- Time since spinal cord injury more than 6 months
- American Spinal Injury Association Impairment Scale (AIS)-D able to walk at least 6 meters with or without technical help
- Ability to understand the study and provide signed informed consent
You will not qualify if you...
- Unstable medical condition such as cancer or acute infections
- Severe spasticity with a score of 3 or higher on the Modified Ashworth scale
- Peripheral nerve problems
- Ulcers on the area where electrodes would be applied
- Intolerance to transcutaneous spinal cord stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants undergo baseline assessments and receive transcutaneous spinal cord stimulation (tSCS) at various spinal segments combined with gait rehabilitation to evaluate effects on gait and neural plasticity.
Multiple visits during 3 weeks for assessments and stimulation sessions
Duration - 1 week
Participants complete a follow-up assessment one week after the last stimulation session to evaluate sustained effects on gait and neurophysiological outcomes.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Institut Guttmann
Badalona, Barcelona, Spain, 08916
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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