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

Primary Purpose

Chronic Stroke

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
active rTMS
sham rTMS
active tDCS
sham tDCS
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring stroke, rTMS, tDCS, robotic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

active rTMS

sham rTMS

active tDCS

sham tDCS

Arm 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

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

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

Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Outcomes

Primary Outcome Measures

Upper Extremity Fugl-Meyer Motor Function Scale
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.

Secondary Outcome Measures

Motor Activity Log-28
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
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
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
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome.
Modified Ashworth Scale
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome
The amplitude of motor evoked potentials (MEPs)
The amplitude of MEP is a common yet highly variable measure of corticospinal excitability.

Full Information

First Posted
November 11, 2021
Last Updated
November 23, 2021
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05134324
Brief Title
The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke
Official Title
The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Anticipated)
Study Completion Date
May 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
stroke, rTMS, tDCS, robotic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active rTMS
Arm Type
Experimental
Arm 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
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm 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
Arm Title
active tDCS
Arm Type
Experimental
Arm 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
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions
Intervention Type
Other
Intervention Name(s)
active rTMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham rTMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
active tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer Motor Function Scale
Description
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
Time Frame
initial, 3th week 9th week changes
Secondary Outcome Measure Information:
Title
Motor Activity Log-28
Description
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.
Time Frame
initial, 3th week 9th week changes
Title
Barthel Index
Description
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.
Time Frame
initial, 3th week 9th week changes
Title
Stroke Impact Scale version 3.0
Description
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.
Time Frame
initial, 3th week 9th week changes
Title
Box and Block Test
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Higher values represent a better outcome.
Time Frame
initial, 3th week 9th week changes
Title
Modified Ashworth Scale
Description
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome
Time Frame
initial, 3th week 9th week changes
Title
The amplitude of motor evoked potentials (MEPs)
Description
The amplitude of MEP is a common yet highly variable measure of corticospinal excitability.
Time Frame
initial, 3th week 9th week changes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Celik Karbancioglu, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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