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

Universidade Federal de Pernambuco

Status: Completed

Conditions: Spinal Cord Injuries (SCI)

Treatments: Device: Repetitive trans-spinal magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06886308

rTsMS_BWSTT_iSCI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

6 participants in 2 patient groups

high-frequency rTsMS + BWSTT

Experimental group

Description:

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.

Treatment:

Device: Repetitive trans-spinal magnetic stimulation

sham rTsMS + BWSTT

Sham Comparator group

Description:

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.

Treatment:

Device: Repetitive trans-spinal magnetic stimulation