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

Spinal Cord Injuries Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248476
• Other study ID #: E2-23-5440
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: Ayse Naz Kalem Özgen
• Phone: 03122911000
• Email: kalemnaz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Transcranial Magnetic Stimulation
Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Training and Research Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity motor score	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	Walking index for spinal cord injury II	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)
Secondary	Spinal cord injury independence measurement III (SCIM III)	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)
Secondary	10 meter walking test	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)
Secondary	Time up and go test	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)
Secondary	Motor evoked potential	For assesment of cortical excitability	Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)