rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
NCT ID: NCT03394560
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2018-01-30
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
High frequency repetitive transcranial magnetic stimulation
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.
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.
Sham High frequency repetitive transcranial magnetic stimulation
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.
Interventions
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High frequency repetitive transcranial magnetic stimulation
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.
Sham High frequency repetitive transcranial magnetic stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Responsible Party
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Fernanda Natacha Rufino Nogueira
Bachelor in physical therapy
Principal Investigators
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Lívia S Nascimento, MSc
Role: STUDY_CHAIR
Applied Neuroscience Laboratory
Marina Berenguer, PT
Role: STUDY_CHAIR
Applied Neuroscience Laboratory
Locations
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Applied Neuroscience Laboratory
Recife, Pernambuco, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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rTMS_BWSTT_SCI
Identifier Type: -
Identifier Source: org_study_id
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