The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562415
• Other study ID #: 5
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: September 2020
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Gaziler PMR, Training and Research Hospital, Department of PMR	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Modified Ashworth Scale	Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.	up to 6 weeks
Secondary	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
Secondary	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
Secondary	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