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

Study Overview
=================
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).

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

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: repetitive transcranial magnetic stimulation therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: real rTMS group<br>motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy | Device: repetitive transcranial magnetic stimulation therapy<br>* 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.<br>* Other names: rehabilitation program;|
| Sham Comparator: sham r TMS<br>motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy | Device: repetitive transcranial magnetic stimulation therapy<br>* 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.<br>* Other names: rehabilitation program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the parameters of gait analysis - walking speed | walking speed (centimeter/second) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - cadence | cadence (number of steps/minute) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - single support time | single support time (second) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - double support time | double support time (second) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - contralateral foot contact time | contralateral foot contact time (second) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - step time | step time (second) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| the parameters of gait analysis - step speed | step speed (centimeter/second)) obtained in the motion analysis laboratory | through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.) | 
| 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) | through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.) | 
| 10-meter Gait Test | 10-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration | through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
r TMS, spinal cord injury, motor recovery,, gait