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

April 30, 2020 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: real rTMS group
motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy
Device: repetitive transcranial magnetic stimulation therapy
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
SHAM_COMPARATOR: sham r TMS
motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy
Device: repetitive transcranial magnetic stimulation therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Study Director: SERDAR KESİKBURUN, MD, TUBİTAK
  • Principal Investigator: AYÇA URAN ŞAN, TUBİTAK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (ACTUAL)

May 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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