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Clinical Trials/NCT06248476
NCT06248476
Completed
Not Applicable

Effect of Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation and Lower Extremity Motor Function in Chronic Spinal Cord Injury Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 site in 1 country30 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
30
Locations
1
Primary Endpoint
Lower extremity motor score
Status
Completed
Last Updated
last year

Overview

Brief Summary

Comparison of different types of transcranial magnetic stimulation techniques which are intermittent theta burst stimulation (iTBS) and high frequency repetitive transcranial magnetic stimulation (rTMS) in patients with spinal cord injury

Detailed Description

iTBS lasts shorter than rTMS so that this technique comfortable than rTMS for both patients and also physicians. Aim of this study is to compare effectiveness of this techniques. If results are same, iTBS can be used instead of rTMS.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ayse Naz Kalem

Asist. Dr.

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Incomplete spinal cord injury (ASIA C and D)
  • 12 months after spinal cord injury
  • At least 10 meters walking independent or with canadian, walker or walking stick
  • Put signature to approved form

Exclusion Criteria

  • Epileptic seizure
  • Pacemaker
  • Pregnancy
  • Neurological disease different from spinal cord injury
  • Metalic implant in brain or scalp
  • Brain surgery
  • Orthopedic problem in lower extremity
  • Malignity

Outcomes

Primary Outcomes

Lower extremity motor score

Time Frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

Assesment of lower extremity key motor muscle function according to American Spinal Injury Association

Secondary Outcomes

  • Spinal cord injury independence measurement III (SCIM III)(Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week))
  • 10 meter walking test(Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week))
  • Walking index for spinal cord injury II(Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week))
  • Time up and go test(Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week))
  • Motor evoked potential(Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week))

Study Sites (1)

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