rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2018
CompletedStudy Start
First participant enrolled
January 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedJanuary 9, 2018
January 1, 2018
7 months
December 22, 2017
January 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
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.
(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 ASIA Impairment Scale (AIS)
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).
(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 (5)
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
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 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 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.
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
Study Arms (2)
high-frequency rTMS + BWSTT
EXPERIMENTALa 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.
sham rTMS + BWSTT
SHAM COMPARATORa 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.
Interventions
Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Neuroscience Laboratory
Recife, Pernambuco, 50670-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lívia S Nascimento, MSc
Applied Neuroscience Laboratory
- STUDY CHAIR
Marina Berenguer, PT
Applied Neuroscience Laboratory
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bachelor in physical therapy
Study Record Dates
First Submitted
December 22, 2017
First Posted
January 9, 2018
Study Start
January 30, 2018
Primary Completion
August 30, 2018
Study Completion
January 31, 2019
Last Updated
January 9, 2018
Record last verified: 2018-01