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
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
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
NCT ID
NCT04372134
First Posted
April 8, 2020
Last Updated
April 30, 2020
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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
Learn more about this trial
The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
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