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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: repetitive transcranial magnetic stimulation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04372134

3

Details and patient eligibility

About

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).

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

real rTMS group

Active Comparator group

Description:

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

Treatment:

Device: repetitive transcranial magnetic stimulation therapy

sham r TMS

Sham Comparator group

Description:

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

Treatment:

Device: repetitive transcranial magnetic stimulation therapy