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Completed

NCT Number: NCT06248476

Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation in Spinal Cord Injury Patients

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field

Primary outcomes

  1. 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

  1. Walking index for spinal cord injury II

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

    Assesment of ambulation ability after spinal cord injury

  2. Spinal cord injury independence measurement III (SCIM III)

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

    Assesment of independence of daily living activities in patients with spinal cord injury

  3. 10 meter walking test

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

    Patients with spinal cord injury walk between two markers, that distance is 10 meters

  4. Time up and go test

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

    Patients sit chair, then walk 3 meter, return and sit again

  5. Motor evoked potential

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

    For assesment of cortical excitability

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Feb 27, 2026

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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