The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Active Continuous Theta Burst Stimulation Therapy; Device: Active Repetitive Transcranial Magnetic Stimulation Therapy; Device: Sham Continuous Theta Burst Stimulation Therapy

• Registration Number: NCT04562415
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-24
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active cTBS group	Active Continuous Theta Burst Stimulation Therapy	chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy
Active rTMS group	Active Repetitive Transcranial Magnetic Stimulation Therapy	chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy
Sham cTBS group	Sham Continuous Theta Burst Stimulation Therapy	chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy

Primary Outcome Measures

Name	Time	Method
Upper Extremity Fugl-Meyer Motor Function Scale	up to 6 weeks	Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
Modified Ashworth Scale	up to 6 weeks	Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Motor Activity Log-28	up to 6 weeks	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	up to 6 weeks	Scale measures upper extremity and hand motor recovery stages (min-max: 1-6). Higher values represent a better outcome.
Functional Independence Measure	up to 6 weeks	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.

Trial Locations

Locations (1)

Gaziler PMR, Training and Research Hospital, Department of PMR; 🇹🇷 Ankara, Çankaya, Turkey