Clinical trial NCT06886308: RTsMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
Official title: FEASIBILITY and PRELIMINARY EFFICACY of REPETITIVE TRANS-SPINAL MAGNETIC STIMULATION for GAIT RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Keywords: spinal cord injury
gait
body weight- support treadmill training
Repetitive Trans-spinal Magnetic Stimulation
Trans-spinal Magnetic Stimulation
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Diagnosed incomplete spinal cord injury established by a neurologist
* Chronic phase (\>1 year)
* 18 and 60 years old, regardless of sex

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
timeFrame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Secondary outcomes:
measure: Changes on ASIA Impairment Scale (AIS)
timeFrame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
measure: Changes on Spinal cord independence measure (Self-Reported) III - (SCIM-III)
timeFrame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
measure: Change from Modified Ashworth scale (MAS)
timeFrame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
measure: Changes on Short-Form Health Survey (SF-36)
timeFrame: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
measure: Changes on Patient Global Impression of Change Scale - (PGICS)
timeFrame: After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Applied Neuroscience Laboratory
name: Vinicius Cipriano, Student of Physical Therapy
role: STUDY_CHAIR
References: