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NCT Number: NCT04372134

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

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).

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation therapy

Device

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.

Other names: rehabilitation program

Primary outcomes

  1. The lower extremity motor scores of the patients

    Time frame: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)

    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 outcomes

  1. the parameters of gait analysis - walking speed

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    walking speed (centimeter/second) obtained in the motion analysis laboratory

  2. the parameters of gait analysis - cadence

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    cadence (number of steps/minute) obtained in the motion analysis laboratory

  3. the parameters of gait analysis - single support time

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    single support time (second) obtained in the motion analysis laboratory

  4. the parameters of gait analysis - double support time

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    double support time (second) obtained in the motion analysis laboratory

  5. the parameters of gait analysis - contralateral foot contact time

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    contralateral foot contact time (second) obtained in the motion analysis laboratory

  6. the parameters of gait analysis - step time

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    step time (second) obtained in the motion analysis laboratory

  7. the parameters of gait analysis - step speed

    Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

    step speed (centimeter/second)) obtained in the motion analysis laboratory

  8. Walking Index for SCI - II (WISCI-II) Scale

    Time frame: through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)

    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)

  9. 10-meter Gait Test

    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-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury

Acronym: rTMS:

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 1, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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