Clinical trial NCT03394560: rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
Official title: Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
transcranial magnetic stimulation
body weight-support treadmill training
gait
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
timeFrame: (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.
measure: Changes on ASIA Impairment Scale (AIS)
timeFrame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention.
Secondary outcomes:
measure: Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)
timeFrame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
measure: Change from Modified Ashworth scale (MAS)
timeFrame: (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.
measure: Changes on Short-Form Health Survey (SF-36)
timeFrame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
measure: Changes on Patient Global Impression of Change Scale - (PGICS)
timeFrame: (i)T0 - after 2 weeks, (ii) T1- after 4 weeks and (iii) T2 - 1 month after the end of the intervention.
measure: Changes on Lower Extremities Motor Scale (LEMS) from ASIA
timeFrame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Applied Neuroscience Laboratory
name: Lívia S Nascimento, MSc
role: STUDY_CHAIR
affiliation: Applied Neuroscience Laboratory
name: Marina Berenguer, PT
role: STUDY_CHAIR
References: