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Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02899637
Recruitment Status : Not yet recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
Universidade Estadual da Paraiba
Information provided by (Responsible Party):
Fernando Henrique Magalhães, University of Sao Paulo

Brief Summary:
The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of patients with iSCI will be conducted.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Active high-frequency Transcranial Magnetic Stimulation Device: Sham high-frequency Transcranial Magnetic Stimulation Not Applicable

Detailed Description:
Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-Frequency Transcranial Magnetic Stimulation on Functional Performance of Subjects With Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spinal Cord Injury (Active Group)
Active high-frequency Transcranial Magnetic Stimulation
Device: Active high-frequency Transcranial Magnetic Stimulation
Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Sham Comparator: Spinal Cord Injury (Control group)
Sham high-frequency Transcranial Magnetic Stimulation
Device: Sham high-frequency Transcranial Magnetic Stimulation
Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week




Primary Outcome Measures :
  1. American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks. [ Time Frame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks. ]
    The ASIA Motor Score is derived from part of the assessment for the International Standards for Neurological Classification of Spinal Cord Injury. It involves testing the strength of ten key muscles on each side of the body in the supine position (e.g., elbow flexors, wrist extensors, hip flexors, quadriceps, dorsiflexors) on a scale of 0 = no contraction to 5 = normal resistance through full range of motion. Scores are summed to give a total possible score of 50 for the upper extremities and 50 for the lower extremities.


Secondary Outcome Measures :
  1. American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score. [ Time Frame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks. ]
    The ASIA Sensory score is also part of the assessment for the International Standard for Neurological Classification of Spinal Cord Injury. It involves testing pinprick and light touch sensation at key points representing each dermatome. Pin-prick and light-touch sensation of each dermatome is separately scored on a 3-point scale (0, 1 and 2). Scores will be summed to give a total possible score of 224 where a higher score indicates better sensation than a lower score.

  2. Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks. [ Time Frame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks. ]
  3. Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks. [ Time Frame: At baseline and after active intervention (i.e five consecutive days of rTMS) and sham (i.e five consecutive days of placebo rTMS). In a period of three weeks. ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a clinical diagnosis of iSCI with nonprogressive etiology
  • Clinical stability
  • Aged between 18-60 years old
  • Score equal to 24 in the Mini-Mental State Examination
  • No electroencephalography alterations
  • Absence of depression assessed by Hamilton Depression Scale
  • Currently receiving inpatient rehabilitation in Physiotherapy Health Center of University of the State of Paraiba, Brazil.

Exclusion Criteria:

  • Have metal prosthesis in some part of the body
  • Use cardiac pacemaker
  • Present dementia or neurological disorders which can increase cortical excitability
  • Have psychotic or schizophrenic disorders
  • Take drugs that reduce seizure threshold or spasticity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899637


Contacts
Contact: Amanda Vitoria L Araujo +55 (11) 971212653 amandavitooria@gmail.com

Locations
Brazil
Universidade Estadual da Paraiba Not yet recruiting
Campina Grande, Paraiba, Brazil, 58429-500
Sponsors and Collaborators
University of Sao Paulo
Universidade Estadual da Paraiba
Investigators
Principal Investigator: Fernando H Magalhaes, Ph.D. University of Sao Paulo

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Henrique Magalhães, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02899637     History of Changes
Other Study ID Numbers: 18753713.0.0000.5187
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fernando Henrique Magalhães, University of Sao Paulo:
Incomplete Spinal Cord Injury
Rehabilitation
Non-invasive brain stimulation
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System