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Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active high-frequency Transcranial Magnetic Stimulation
Sham high-frequency Transcranial Magnetic Stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Incomplete Spinal Cord Injury, Rehabilitation, Non-invasive brain stimulation, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Estadual da Paraiba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal Cord Injury (Active Group)

Spinal Cord Injury (Control group)

Arm Description

Active high-frequency Transcranial Magnetic Stimulation

Sham high-frequency Transcranial Magnetic Stimulation

Outcomes

Primary Outcome Measures

American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to 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

American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.
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.
Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks.
Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks.

Full Information

First Posted
August 25, 2016
Last Updated
September 13, 2016
Sponsor
University of Sao Paulo
Collaborators
Universidade Estadual da Paraiba
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1. Study Identification

Unique Protocol Identification Number
NCT02899637
Brief Title
Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Universidade Estadual da Paraiba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Incomplete Spinal Cord Injury, Rehabilitation, Non-invasive brain stimulation, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury (Active Group)
Arm Type
Experimental
Arm Description
Active high-frequency Transcranial Magnetic Stimulation
Arm Title
Spinal Cord Injury (Control group)
Arm Type
Sham Comparator
Arm Description
Sham high-frequency Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Active high-frequency Transcranial Magnetic Stimulation
Intervention Description
Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week
Intervention Type
Device
Intervention Name(s)
Sham high-frequency Transcranial Magnetic Stimulation
Intervention Description
Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week
Primary Outcome Measure Information:
Title
American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks.
Description
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.
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.
Secondary Outcome Measure Information:
Title
American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.
Description
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.
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Vitoria L Araujo
Phone
+55 (11) 971212653
Email
amandavitooria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando H Magalhaes, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual da Paraiba
City
Campina Grande
State/Province
Paraiba
ZIP/Postal Code
58429-500
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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15111994
Citation
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Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

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