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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT06248476
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham iTBS + robotic rehabilitation	Transcranial Magnetic Stimulation	Sham iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
iTBS + robotic rehabilitation	Transcranial Magnetic Stimulation	iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
rTMS + robotic rehabilitation	Transcranial Magnetic Stimulation	rTMS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury

Primary Outcome Measures

Name	Time	Method
Lower extremity motor score	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 Outcome Measures

Name	Time	Method
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)	Assesment of independence of daily living activities in patients with spinal cord injury
10 meter walking test	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
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)	Assesment of ambulation ability after spinal cord injury
Time up and go test	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
Motor evoked potential	Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)	For assesment of cortical excitability

Trial Locations

Locations (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital; 🇹🇷 Ankara, Çankaya, Turkey