The Effects of rTMS and tDCS Combined With Robotic Rehabilitation In Patients With Spinal Cord Injury
NCT ID: NCT06188130
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-01-15
2024-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active rTMS
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
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.
sham rTMS
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
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.
active tDCS
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
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.
sham tDCS
Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions
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
Interventions
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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.
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.
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Emre Adıgüzel
Emre Adıgüzel, Associate professor, Ankara City Hospital Bilkent
Principal Investigators
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Emre Adıgüzel
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Locations
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Ankara Bilkent City Hospital Pyhsical Treatment and Rehabilitation Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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10025144
Identifier Type: -
Identifier Source: org_study_id
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