Clinical trial NCT04562415: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Repetitive Transcranial Magnetic Stimulation
Continuous Theta Burst Stimulation
Functional Recovery
Spasticity
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Upper Extremity Fugl-Meyer Motor Function Scale
timeFrame: up to 6 weeks
measure: Modified Ashworth Scale
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: up to 6 weeks
measure: Motor Activity Log-28
timeFrame: up to 6 weeks
measure: Brunnstrom Motor Recovery Scale
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler PMR, Training and Research Hospital, Department of PMR
state: Çankaya
Study officials:
affiliation: Gaziler PMR, Training and Research Hospital, Department of PMR
name: Bilge Yılmaz, Professor,MD
role: STUDY_DIRECTOR
affiliation: Gaziler PMR, Training and Research Hospital, Department of PMR
name: Ömer Kuzu, MD
role: PRINCIPAL_INVESTIGATOR
References: