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

Universidade Federal de Pernambuco

Status and phase: Unknown; Phase 2

Conditions: Spinal Cord Injuries

Treatments: Device: Sham High frequency repetitive transcranial magnetic stimulation; Device: High frequency repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03394560

rTMS_BWSTT_SCI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

high-frequency rTMS + BWSTT

Experimental group

Description:

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.

Treatment:

Device: High frequency repetitive transcranial magnetic stimulation

sham rTMS + BWSTT

Sham Comparator group

Description:

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.

Treatment:

Device: Sham High frequency repetitive transcranial magnetic stimulation