The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke
NCT ID: NCT05134324
Last Updated: 2021-11-24
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
2021-05-25
2022-05-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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active rTMS
Participants recevied 1 Hz low frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for upper extremity just after each active TMS sessions
active rTMS
Participants recevied 1 Hz low 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 contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper 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 upper 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 upper 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 upper 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 C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper 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 upper extremity just after each sham tDCS sessions
Interventions
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active rTMS
Participants recevied 1 Hz low 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 contralateral abductor pollicis brevis (APB).The patient received robotic therapy for upper 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 upper 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 C3/C4 (International 10/20 Electroencephalogram System) area, corresponding to the location of the affected hemisphere primary motor cortex (M1), and cathodal to the contralateral supraorbital region. The patient received robotic therapy for upper 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 upper extremity just after each sham tDCS sessions
Eligibility Criteria
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Inclusion Criteria
* aged based 18 years
* first stroke
* Mini mental test score ≥ 22
* upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
* Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC
Exclusion Criteria
* history of epilepsy
* a cardiac pacemaker
* pregnancy
* Fugl Meyer upper extremity assessment score ≥44
* history of previous stroke or ischemic attack
* neurological diseases other than stroke
* metallic implant in brain or scalp (including cochlear implant)
* previous brain surgery
* orthopedic disease that prevents upper extremity movements
* diagnosis of malignancy
* receiving robotic /TMS/tDCS treatments in the last 6 months
18 Years
ALL
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Associate professor
Principal Investigators
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Esra Celik Karbancioglu, MD
Role: STUDY_DIRECTOR
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Locations
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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22
Identifier Type: -
Identifier Source: org_study_id