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

NCT ID: NCT06886308

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-08-31

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).

Conditions

Spinal Cord Injuries (SCI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

high-frequency rTsMS + BWSTT

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.

Group Type: EXPERIMENTAL

Repetitive trans-spinal magnetic stimulation

Intervention Type: DEVICE

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.

sham rTsMS + BWSTT

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.

Group Type: SHAM_COMPARATOR

Repetitive trans-spinal magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Body Weight-support Treadmill Training

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Natacha Rufino Nogueira

Master in Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinicius Cipriano, Student of Physical Therapy

Role: STUDY_CHAIR

Applied Neuroscience Laboratory

Locations

Applied Neuroscience Laboratory

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

rTsMS_BWSTT_iSCI

Identifier Type: -

Identifier Source: org_study_id