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

November 23, 2021 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.
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
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.
SHAM_COMPARATOR: sham tDCS
Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
initial, 3th week 9th week changes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
initial, 3th week 9th week changes
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.
initial, 3th week 9th week changes
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.
initial, 3th week 9th week changes
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.
initial, 3th week 9th week changes
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
initial, 3th week 9th week changes
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.
initial, 3th week 9th week changes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Study Director: Esra Celik Karbancioglu, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2021

Primary Completion (ANTICIPATED)

February 25, 2022

Study Completion (ANTICIPATED)

May 25, 2022

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (ACTUAL)

November 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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