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
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Oct 2018
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 19, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedSeptember 28, 2020
September 1, 2020
7 months
September 19, 2020
September 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Functional Independence Measure
up to 6 weeks
Motor Activity Log-28
up to 6 weeks
Brunnstrom Motor Recovery Scale
up to 6 weeks
Study Arms (3)
Active rTMS group
ACTIVE COMPARATORchronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy
Active cTBS group
ACTIVE COMPARATORchronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy
Sham cTBS group
SHAM COMPARATORchronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Çankaya, 06100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
September 19, 2020
First Posted
September 24, 2020
Study Start
October 1, 2018
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
September 28, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share