Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
Study Overview
Brief Summary
The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.
Detailed Description
A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). Active or sham rTMS will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. Behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the T1 level).
- •Duration injury of at least 8 months.
- •Presented degree of C or D according to the ASIA Impairment Scale (AIS) scale of the American Spinal Cord Injury Association.
- •Patients who are not community walkers.
Exclusion Criteria
- •Pregnant women;
- •Pacemaker;
- •Historic of seizures;
- •Metallic implants in the head;
- •Patients with clinical evidence of brain injuries;
- •Patients with neurological and / or orthopedic pathologies that have repercussion on a gait and the disadvantages
- •Use of neuroleptic medications.
Arms & Interventions
high-frequency rTMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month.
Intervention: High frequency repetitive transcranial magnetic stimulation (Device)
sham rTMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month.
Intervention: Sham High frequency repetitive transcranial magnetic stimulation (Device)
Outcomes
Primary Outcomes
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
Time Frame: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the 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.
Changes on ASIA Impairment Scale (AIS)
Time Frame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention.
this is international scale, it is the gold standard for the diagnosis of spinal cord injury and is used worldwide. The AIS categorizes the lesion from full spinal cord injury to normal degree, according to sensory-motor preservation, passing through 3 degrees of spinal cord injury (A , B, C, D or E).
Secondary Outcomes
- Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Changes on Short-Form Health Survey (SF-36)((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Changes on Lower Extremities Motor Scale (LEMS) from ASIA((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Change from Modified Ashworth scale (MAS)((i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.)
- Changes on Patient Global Impression of Change Scale - (PGICS)((i)T0 - after 2 weeks, (ii) T1- after 4 weeks and (iii) T2 - 1 month after the end of the intervention.)
Investigators
Fernanda Natacha Rufino Nogueira
Bachelor in physical therapy
Universidade Federal de Pernambuco