The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Active Repetitive Transcranial Magnetic Stimulation Therapy; Device: Active Continuous Theta Burst Stimulation Therapy; Device: Sham Continuous Theta Burst Stimulation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06100
      • Gaziler PMR, Training and Research Hospital, Department of PMR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active rTMS group; chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy	Device: Active Repetitive Transcranial Magnetic Stimulation Therapy; 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.; Other Names: Rehabilitation Program
Active Comparator: Active cTBS group; chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy	Device: Active Continuous Theta Burst Stimulation Therapy; 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.; Other Names: Rehabilitation Program
Sham Comparator: Sham cTBS group; chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy	Device: Sham Continuous Theta Burst Stimulation Therapy; 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.; Other Names: Rehabilitation Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 weeks
Modified Ashworth Scale	Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 weeks
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.	up to 6 weeks
Brunnstrom Motor Recovery Scale	Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome.	up to 6 weeks

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Study Director: Bilge Yılmaz, Professor,MD, Gaziler PMR, Training and Research Hospital, Department of PMR; Principal Investigator: Ömer Kuzu, MD, Gaziler PMR, Training and Research Hospital, Department of PMR

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: September 19, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Spasticity; Repetitive Transcranial Magnetic Stimulation; Functional Recovery; Continuous Theta Burst Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 5

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