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

February 25, 2026 updated by: Ayse Naz Kalem, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06800
        • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

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

  • Adult

Accepts Healthy Volunteers

No

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iTBS + robotic rehabilitation
iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field
Active Comparator: rTMS + robotic rehabilitation
rTMS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field
Sham Comparator: sham iTBS + robotic rehabilitation
Sham iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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)

March 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-23-5440

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Transcranial Magnetic Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe