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The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation) (rTMS:)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation therapy
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring r TMS, spinal cord injury, motor recovery,, gait

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
  • the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.

Exclusion Criteria:

  • the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
  • family history of epilepsy
  • the presence of brain injury
  • the presence of cranium defect
  • the presence of pacemaker
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    real rTMS group

    sham r TMS

    Arm Description

    motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy

    motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy

    Outcomes

    Primary Outcome Measures

    The lower extremity motor scores of the patients
    The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)

    Secondary Outcome Measures

    the parameters of gait analysis - walking speed
    walking speed (centimeter/second) obtained in the motion analysis laboratory
    the parameters of gait analysis - cadence
    cadence (number of steps/minute) obtained in the motion analysis laboratory
    the parameters of gait analysis - single support time
    single support time (second) obtained in the motion analysis laboratory
    the parameters of gait analysis - double support time
    double support time (second) obtained in the motion analysis laboratory
    the parameters of gait analysis - contralateral foot contact time
    contralateral foot contact time (second) obtained in the motion analysis laboratory
    the parameters of gait analysis - step time
    step time (second) obtained in the motion analysis laboratory
    the parameters of gait analysis - step speed
    step speed (centimeter/second)) obtained in the motion analysis laboratory
    Walking Index for SCI - II (WISCI-II) Scale
    Walking Index for SCI - II (WISCI-II) Scale (WISCI -II is a scale to assess the amount of physical assistance needed as well as device reuired for walking ( The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former)
    10-meter Gait Test
    10-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration

    Full Information

    First Posted
    April 8, 2020
    Last Updated
    April 30, 2020
    Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04372134
    Brief Title
    The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
    Acronym
    rTMS:
    Official Title
    The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).
    Detailed Description
    A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    r TMS, spinal cord injury, motor recovery,, gait

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    real rTMS group
    Arm Type
    Active Comparator
    Arm Description
    motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy
    Arm Title
    sham r TMS
    Arm Type
    Sham Comparator
    Arm Description
    motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy
    Intervention Type
    Device
    Intervention Name(s)
    repetitive transcranial magnetic stimulation therapy
    Other Intervention Name(s)
    rehabilitation program
    Intervention Description
    A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.
    Primary Outcome Measure Information:
    Title
    The lower extremity motor scores of the patients
    Description
    The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)
    Secondary Outcome Measure Information:
    Title
    the parameters of gait analysis - walking speed
    Description
    walking speed (centimeter/second) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - cadence
    Description
    cadence (number of steps/minute) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - single support time
    Description
    single support time (second) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - double support time
    Description
    double support time (second) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - contralateral foot contact time
    Description
    contralateral foot contact time (second) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - step time
    Description
    step time (second) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    the parameters of gait analysis - step speed
    Description
    step speed (centimeter/second)) obtained in the motion analysis laboratory
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
    Title
    Walking Index for SCI - II (WISCI-II) Scale
    Description
    Walking Index for SCI - II (WISCI-II) Scale (WISCI -II is a scale to assess the amount of physical assistance needed as well as device reuired for walking ( The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former)
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)
    Title
    10-meter Gait Test
    Description
    10-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration
    Time Frame
    through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form. Exclusion Criteria: the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris) family history of epilepsy the presence of brain injury the presence of cranium defect the presence of pacemaker pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SERDAR KESİKBURUN, MD
    Organizational Affiliation
    TUBİTAK
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    AYÇA URAN ŞAN
    Organizational Affiliation
    TUBİTAK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)

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