The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Stroke

Treatments: Device: Sham Continuous Theta Burst Stimulation Therapy; Device: Active Repetitive Transcranial Magnetic Stimulation Therapy; Device: Active Continuous Theta Burst Stimulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04562415

5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Active rTMS group

Active Comparator group

Description:

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

Treatment:

Device: Active Repetitive Transcranial Magnetic Stimulation Therapy

Active cTBS group

Active Comparator group

Description:

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

Treatment:

Device: Active Continuous Theta Burst Stimulation Therapy

Sham cTBS group

Sham Comparator group

Description:

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

Treatment:

Device: Sham Continuous Theta Burst Stimulation Therapy