NCT06886308

RTsMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

FEASIBILITY and PRELIMINARY EFFICACY of REPETITIVE TRANS-SPINAL MAGNETIC STIMULATION for GAIT RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Universidade Federal de Pernambuco · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Spinal Cord Injuries (SCI)

Interventions

Type	Name	Description
DEVICE	Repetitive trans-spinal magnetic stimulation	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-05-20
• Completion: 2023-08-31
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: Brazil