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

Ankara City Hospital

Status: Active, not recruiting

Conditions: Chronic Spinal Cord Disorder

Treatments: Other: sham tDCS; Other: active rTMS; Other: sham rTMS; Other: active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06188130

10025144

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having traumatic SCI
• Between 6 months and 2 years after SCI
• 18-65 years old
• Signing an informed consent form showing his/her consent to participate in the study.
• Motor incomplete cervical or thoracic SCI
• Spasticity in the lower extremity ≤2 according to the Modified Ashworth Scale

Exclusion criteria

• History of epilepsy
• A cardiac pacemaker
• Pregnancy
• Neurological diseases other than SCI
• Metallic implant in brain or scalp (including cochlear implant)
• Previous brain surgery
• Orthopedic disease that prevents lower extremity movements
• Diagnosis of malignancy
• Receiving robotic /TMS/tDCS treatments in the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

active rTMS

Experimental group

Description:

Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for lower extremity just after each active TMS sessions

Treatment:

Other: active rTMS

sham rTMS

Sham Comparator group

Description:

Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for lower extremity just after each sham TMS sessions

Treatment:

Other: sham rTMS

active tDCS

Experimental group

Description:

Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for lower extremity just after each active tDCS sessions

Treatment:

Other: active tDCS

sham tDCS

Sham Comparator group

Description:

Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Treatment:

Other: sham tDCS