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The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Active Repetitive Transcranial Magnetic Stimulation Therapy
Active Continuous Theta Burst Stimulation Therapy
Sham Continuous Theta Burst Stimulation Therapy
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 Stroke focused on measuring Stroke, Repetitive Transcranial Magnetic Stimulation, Continuous Theta Burst Stimulation, Functional Recovery, Spasticity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ischemic stroke with a disease interval of 6 months to 2 years
  • aged between 18-80 years
  • Mini mental test score ≥ 24
  • upper limb Brunnstrom recovery stage 3 to 5
  • upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3

Exclusion Criteria:

  • hemorrhagic stroke
  • history of epilepsy
  • a cardiac pacemaker
  • pregnancy
  • 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
  • poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.)
  • diagnosis of malignancy
  • injections of botulinum toxin in the last 6 months for the affected upper extremity
  • drug or dosage changes of anti-spasticity medications in the last 1 month period

Sites / Locations

  • Gaziler PMR, Training and Research Hospital, Department of PMR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active rTMS group

Active cTBS group

Sham cTBS group

Arm Description

chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy

chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy

chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy

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.
Modified Ashworth Scale
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.

Secondary Outcome Measures

Functional Independence Measure
Scale measures level of independence on activities of daily life (min-max: 18-126 points). Self-care part of the motor subscale was used in this study (min-max:6-42 points). Higher values represent a better outcome.
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.
Brunnstrom Motor Recovery Scale
Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome.

Full Information

First Posted
September 19, 2020
Last Updated
September 24, 2020
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04562415
Brief Title
The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke
Official Title
The Effect Of Sham Controlled Continuous Theta Burst Stimulation And Low Frequency Repetitive Transcranial Magnetic Stimulation On Upper Extremity Spasticity And Functional Recovery In Patients With Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

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
This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.
Detailed Description
A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Repetitive Transcranial Magnetic Stimulation, Continuous Theta Burst Stimulation, Functional Recovery, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS group
Arm Type
Active Comparator
Arm Description
chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy
Arm Title
Active cTBS group
Arm Type
Active Comparator
Arm Description
chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy
Arm Title
Sham cTBS group
Arm Type
Sham Comparator
Arm Description
chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy
Intervention Type
Device
Intervention Name(s)
Active Repetitive Transcranial Magnetic Stimulation Therapy
Other Intervention Name(s)
Rehabilitation Program
Intervention Description
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
Intervention Type
Device
Intervention Name(s)
Active Continuous Theta Burst Stimulation Therapy
Other Intervention Name(s)
Rehabilitation Program
Intervention Description
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
Intervention Type
Device
Intervention Name(s)
Sham Continuous Theta Burst Stimulation Therapy
Other Intervention Name(s)
Rehabilitation Program
Intervention Description
10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
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
up to 6 weeks
Title
Modified Ashworth Scale
Description
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Functional Independence Measure
Description
Scale measures level of independence on activities of daily life (min-max: 18-126 points). Self-care part of the motor subscale was used in this study (min-max:6-42 points). Higher values represent a better outcome.
Time Frame
up to 6 weeks
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
up to 6 weeks
Title
Brunnstrom Motor Recovery Scale
Description
Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome.
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ischemic stroke with a disease interval of 6 months to 2 years aged between 18-80 years Mini mental test score ≥ 24 upper limb Brunnstrom recovery stage 3 to 5 upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3 Exclusion Criteria: hemorrhagic stroke history of epilepsy a cardiac pacemaker pregnancy 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 poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.) diagnosis of malignancy injections of botulinum toxin in the last 6 months for the affected upper extremity drug or dosage changes of anti-spasticity medications in the last 1 month period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilge Yılmaz, Professor,MD
Organizational Affiliation
Gaziler PMR, Training and Research Hospital, Department of PMR
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ömer Kuzu, MD
Organizational Affiliation
Gaziler PMR, Training and Research Hospital, Department of PMR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziler PMR, Training and Research Hospital, Department of PMR
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

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