Spinal Cord Injuries (SCI)NCT06886308
RTsMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
A study testing Repetitive trans-spinal magnetic stimulation in people with Spinal Cord Injuries (SCI), run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The aim of this study is to assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Repetitive trans-spinal magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed incomplete spinal cord injury established by a neurologist
- Chronic phase (>1 year)
- 18 and 60 years old, regardless of sex
Who cannot join
- Community ambulators
- Could not maintain an orthostatic position for 30 seconds without assistance
- Associated neurological and/or orthopedic conditions
- Contraindications for rTsMS
- Diagnosis of cardiac dysfunction, angina, or hemodynamic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FEASIBILITY and PRELIMINARY EFFICACY of REPETITIVE TRANS-SPINAL MAGNETIC STIMULATION for GAIT RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY
The aim of this study is to assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.
Read the detailed description
A randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). Active or sham rTsMS will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. Assessments will be performed before, after 5 and 10 therapeutic sessions, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Repetitive trans-spinal magnetic stimulation
- Keywords
- spinal cord injury, gait, body weight- support treadmill training, Repetitive Trans-spinal Magnetic Stimulation, Trans-spinal Magnetic Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive trans-spinal magnetic stimulationDevice
Also called Body Weight-support Treadmill Training
For repetitive trans-spinal magnetic stimulation - rTsMS (high-frequency or sham), volunteers will be positioned comfortably in a lateral decubitus position. High-frequency rTsMS will be applied with an eight-shaped coil over the tenth thoracic vertebra (10 Hz; 100 pulses per train, 20-second interval between trains; 100% resting motor threshold). For sham rTsMS, two coils will be used: (i) a coil connected to the stimulator will be placed behind the patient (away from the spine) to generate the characteristic sound, and (ii) another coil, disconnected from the stimulator, will be placed on the tenth thoracic vertebra. Both real and sham stimulation will last 20 minutes. Gait training with body weight support will be performed on a Biodex Rehabilitation treadmill for 20 minutes. Researchers will assist the patient in foot placement, knee extension, and pelvis/trunk alignment. Body weight support and treadmill speed will be adjusted based on the patient's performance.
| Study group | Role | What they receive |
|---|---|---|
| high-frequency rTsMS + BWSTT | Experimental | a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between high-frequency rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury. Receives: Device: Repetitive trans-spinal magnetic stimulation |
| sham rTsMS + BWSTT | Sham comparator | a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between sham rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury. Receives: Device: Repetitive trans-spinal magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices. The higher the score, the greater the independence in gait.
Measured: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Secondary outcomes (5)
Changes on ASIA Impairment Scale (AIS)
Sensory-motor function was assessed using the AIS. This assessment measure is part of the guidelines provided by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), created by the American Spinal Injury Association. Using the AIS, motor function was measured by the total score of the Upper Extremities Motor Scale (UEMS) and Lower Extremities Motor Scale (LEMS). The UEMS and LEMS are made up of the sum of the strength levels of ten main muscles. Each muscle was given a score ranging from '0' to '5', according to the manual muscle strength assessment scale. Sensory function was measured by the total score of two sensory components assessed in the AIS: 'light touch (LT)' and 'pinprick (PP)'. To assess sensory function, stimuli were applied to the dermatomes as described in the ASIA standardised manuals. The score for each component of the dermatome varies from '0 to 2': 0 = no sensation, 1 = altered sensation and 2 = preserved sensation.
Measured: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Spinal cord independence measure (Self-Reported) III - (SCIM-III)
The scale evaluates a patient's ability to perform tasks related to spinal cord injury and tracks improvements in their functional capacity. The SCIM-III scale ranges from 0 to 100 points and is divided into three primary domains: self-care (feeding, bathing, dressing, and hygiene), breathing, sphincter control, and mobility (both indoor and outdoor activities, including transfers). The higher the score on the scale, the greater the functional independence.
Measured: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Change from Modified Ashworth scale (MAS)
The Modified Ashworth Scale employs a 6-point system to measure the average resistance to passive movement at each joint. In this study, it will assess the following muscle groups: hip flexors and extensors, knee flexors and extensors, and ankle dorsiflexors and plantar flexors. The higher the score on the scale, the greater the degree of spasticity.
Measured: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Short-Form Health Survey (SF-36)
The SF-36 is a multidimensional questionnaire consisting of 36 items, encompassed in eight scales or components: i. Functional capacity - 10 items, ii. Limitation by physical resources - 4 items, iii. Pain - 2 items, iv. General health status - 5 items, v. Vitality - 4 items, vi. Social Aspects - 2 items, vii. Limitation by emotional aspects - 3 items, viii. Mental Health - 5 items and one comparative question more for assessment between how current health conditions and a year ago.
Measured: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Patient Global Impression of Change Scale - (PGICS)
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better". This scale has already been validated in Brazil and has been used in clinical practice assays with spinal cord injury.
Measured: After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2022
- Primary completion20 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Natacha Rufino Nogueira, Universidade Federal de Pernambuco
- Investigators
- Vinicius Cipriano, Student of Physical Therapy, Study chair, Applied Neuroscience Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886308
- Sponsor's protocol ID
- rTsMS_BWSTT_iSCI
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY and PRELIMINARY EFFICACY of REPETITIVE TRANS-SPINAL MAGNETIC STIMULATION for GAIT RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY
- ClinicalTrials.gov ID
- NCT06886308
- Acronym / sponsor ID
- rTsMS_BWSTT_iSCI
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- spinal cord injury, gait, body weight- support treadmill training, Repetitive Trans-spinal Magnetic Stimulation, Trans-spinal Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 20 Mar 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.
The aim of this study is to assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.
Detailed description
A randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). Active or sham rTsMS will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. Assessments will be performed before, after 5 and 10 therapeutic sessions, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-frequency rTsMS + BWSTT | Experimental | Device: Repetitive trans-spinal magnetic stimulationa randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between high-frequency rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury. |
| sham rTsMS + BWSTT | Sham comparator | Device: Repetitive trans-spinal magnetic stimulationa randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between sham rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed incomplete spinal cord injury established by a neurologist
- Chronic phase (>1 year)
- 18 and 60 years old, regardless of sex
Key exclusion criteria (5 listed)
- Community ambulators
- Could not maintain an orthostatic position for 30 seconds without assistance
- Associated neurological and/or orthopedic conditions
- Contraindications for rTsMS
- Diagnosis of cardiac dysfunction, angina, or hemodynamic disorders
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 |
|---|---|---|
| Repetitive trans-spinal magnetic stimulationAlso: Body Weight-support Treadmill TrainingFor repetitive trans-spinal magnetic stimulation - rTsMS (high-frequency or sham), volunteers will be positioned comfortably in a lateral decubitus position. High-frequency rTsMS will be applied with an eight-shaped coil over the tenth thoracic vertebra (10 Hz; 100 pulses per train, 20-second interval between trains; 100% resting motor threshold). For sham rTsMS, two coils will be used: (i) a coil connected to the stimulator will be placed behind the patient (away from the spine) to generate the characteristic sound, and (ii) another coil, disconnected from the stimulator, will be placed on the tenth thoracic vertebra. Both real and sham stimulation will last 20 minutes. Gait training with body weight support will be performed on a Biodex Rehabilitation treadmill for 20 minutes. Researchers will assist the patient in foot placement, knee extension, and pelvis/trunk alignment. Body weight support and treadmill speed will be adjusted based on the patient's performance. | Device | high-frequency rTsMS + BWSTT, sham rTsMS + BWSTT |
Primary outcome
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
Time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices. The higher the score, the greater the independence in gait.
5 secondary outcomes
Changes on ASIA Impairment Scale (AIS)
Time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Spinal cord independence measure (Self-Reported) III - (SCIM-III)
Time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Change from Modified Ashworth scale (MAS)
Time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Short-Form Health Survey (SF-36)
Time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Changes on Patient Global Impression of Change Scale - (PGICS)
Time frame: After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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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. This study is not recruiting at the moment.
Vinicius Cipriano, Student of Physical Therapy study chair
Applied Neuroscience Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive trans-spinal magnetic stimulation in people with Spinal Cord Injuries (SCI), run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 20 Mar 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on Walking Index for Spinal Cord Injury II (WISCI-II) (time frame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).). 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 20 Mar 2025.