Clinical trial NCT04372134: The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)
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
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: r TMS
spinal cord injury
motor recovery,
gait
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The lower extremity motor scores of the patients
timeFrame: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)
Secondary outcomes:
measure: the parameters of gait analysis - walking speed
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - cadence
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - single support time
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - double support time
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - contralateral foot contact time
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - step time
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: the parameters of gait analysis - step speed
timeFrame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
measure: Walking Index for SCI - II (WISCI-II) Scale
timeFrame: through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)
measure: 10-meter Gait Test
timeFrame: through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)
Other outcomes:
Locations:
Study officials:
affiliation: The Scientific and Technological Research Council of Turkey
name: SERDAR KESİKBURUN, MD
role: STUDY_DIRECTOR
affiliation: The Scientific and Technological Research Council of Turkey
name: AYÇA URAN ŞAN
role: PRINCIPAL_INVESTIGATOR
References: