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

Overview

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

Full Title of Study: “The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 25, 2022

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.

Interventions

  • Other: 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.
  • 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 upper 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 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.
  • 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 upper extremity just after each sham tDCS sessions

Arms, Groups and Cohorts

  • Experimental: 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
  • Sham Comparator: 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
  • Experimental: 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
  • Sham Comparator: sham tDCS
    • Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Clinical Trial Outcome Measures

Primary Measures

  • Upper Extremity Fugl-Meyer Motor Function Scale
    • Time Frame: initial, 3th week 9th week changes
    • Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.

Secondary Measures

  • Motor Activity Log-28
    • Time Frame: initial, 3th week 9th week changes
    • Scale measures frequency of use and functionality level of the affected upper limb during daily activities (min-max: 0-5 points). Higher values represent a better outcome.
  • Barthel Index
    • Time Frame: initial, 3th week 9th week changes
    • Scale measures performance in activities of daily living. The Index yields a total score out of 100 – the higher the score, the greater the degree of functional independence.
  • Stroke Impact Scale version 3.0
    • Time Frame: initial, 3th week 9th week changes
    • Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better Scores for each domain range from 0 to 100, and higher scores indicate a better. The scale also includes a question (item 50) to assess the patient’s global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery.
  • Box and Block Test
    • Time Frame: initial, 3th week 9th week changes
    • The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome.
  • Modified Ashworth Scale
    • Time Frame: initial, 3th week 9th week changes
    • Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome
  • The amplitude of motor evoked potentials (MEPs)
    • Time Frame: initial, 3th week 9th week changes
    • The amplitude of MEP is a common yet highly variable measure of corticospinal excitability.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yasin Demir, Associate professor – Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
  • Overall Official(s)
    • Esra Celik Karbancioglu, MD, Study Director, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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