The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Unknown

Conditions: Chronic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05134324

22

Details and patient eligibility

About

The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

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 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ischemic stroke with a disease interval of 6 months to 2 years
• 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

• hemorrhagic stroke
• 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

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 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

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 upper 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 upper 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