NCT06188130

The Effects of rTMS and tDCS Combined With Robotic Rehabilitation In Patients With Spinal Cord Injury

The Effect of rTMS and tDCS Treatments Combined With Robotic Rehabilitation on Gait and Motor Recovery in Partial Chronic Spinal Cord Injury

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters

Detailed description

After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.

Conditions

• Chronic Spinal Cord Disorder

Interventions

Type	Name	Description
OTHER	active rTMS	Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed dominant side abductor pollicis brevis (APB).The patient received robotic therapy for lower extremity just after each active TMS sessions.
OTHER	sham rTMS	Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for lower extremity just after each sham TMS sessions.
OTHER	active tDCS	Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the Cz central (International 10/20 Electroencephalogram System) area, corresponding to the location of the dominant hemisphere lower extremity motor cortex and cathodal to the contralateral supraorbital region. The patient received robotic therapy for lower extremity just after each active tDCS sessions.
OTHER	sham tDCS	Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for lower extremity just after each sham tDCS sessions

Timeline

• Start date: 2021-01-15
• Primary completion: 2023-12-30
• Completion: 2024-01-15
• First posted: 2024-01-03
• Last updated: 2024-01-03

Locations

1 site across 1 country: Turkey (Türkiye)