Reduction of complications in brain trauma patients using RTMS technique and evaluation of RTMS effect on spasticity of patients
Design
40 susceptible patients suffering from traumatic brain injury have been divided into intervention and control groups. A blind, parallel, randomized strain
Settings and conduct
A sample of 40 patients referring to the Rehabilitation Center of Shahid Rajaee Hospital in 2018-2019, who are suffering from spastic brain injury due to truma, are selected. The motor cortex is stimulated by 8-shaped coil with the magnetic stimulation pattern. Magnetic stimulation is applied with the following characteristics: Frequency: 1 Hz / Number of pulses: 1500 / Severity: 90% of the motor threshold. Each person receives transcranial magnetic stimulation (TMS) per day for 10 days. Prior to intervention, muscle spasticity, Muscle strength and daily activity levels are evaluated and the same evaluations are performed again at the end of the intervention. The patient and the examiner are unaware of the intervention being performed or not performed and device kept off in the control group by the technician .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18-75, non-history of ischemic stroke or hemorrhagic and multiple sclerosis, muscle spasticity with grades 3 and 4, strength of 3rd grade. No dryness and joint adhesion. Non-major fractures, no history of skull surgery in the past. No history of cardiac arrhythmia. Exclusion criteria: history of cerebral aneurysm or seizure, history of metal or clips implants, unstable vital signs, chronic pain
Intervention groups
The patients are randomly assigned to both case and control groups. The group under RTMS and the control group are studied by the coil off of the sham stimulation device.
Efficacy of Repetitive Transcranial Magnetic Stimulation to Reduce Muscle Spasticity in Patients with Traumatic Brain Injury
Public title
Efficacy of Repetitive Transcranial Magnetic Stimulation to Reduce Muscle Spasticity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 and under 75 years
presence of muscle spasticity at grades 3 and 4 in at least one of the muscle compartments
With muscle_ power grading over 3
Exclusion criteria:
History of ischemic or hemorrhage stroke and multiple sclerosis
Existence of joint dryness and adhesion
Major fractures and history of cerebral cranial surgeries in the past
positive history of cardiac arrhythmias
positive history of brain aneurysm or seizure (focal or generalized)
history of surgery involving metal or clips implants
unstable Vital signs
Chronic Pain
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment method In this study, the method of the permutation block will be such that A represents the person receiving the intervention and B represents the person who does not receive the intervention. This method, taking into account the six-membered blocks so that the total number of possible quadrupole permutations is equal to 4, includes: AABB, ABAB, BABA, BBAA. Then, with Using the random numbers table and assigning the code from 0 to 9 to each permutation, (randomized list of 60) (considering the drop in patients from the study), which includes 15 blocks of 4 (60 * 4 * 60 total number of samples ) And the order of assignment of each method to each of the participating samples is determined.
For example: (ABAB Code 0, AABB Code 1, BABA Code 2, BBAA Code 3 to 9)
Then, using the random numbers table, the starting point is selected randomly and 15 randomly selected (row or column) is selected and the assigned permutation is written to each number. (The order of placing permutations next to each other is left to right respectively) and how all 60 people will be assigned to the two groups A and B
Blinding (investigator's opinion)
Double blinded
Blinding description
The control group was studied by the coil off of the sham stimulation device.
The patient's examiner who evaluates spasticity is not aware of the lack or existence of the device .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fifth Floor, Central Building of Shiraz University, Jomhuory Boulevard
City
Shiraz
Province
Fars
Postal code
71946-84471
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.SUMS.MED.REC.1396.82
Health conditions studied
1
Description of health condition studied
Spasticity in traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
muscle tone
Timepoint
The beginning of the study, before and after each intervention, one month after the end of the interventions
Method of measurement
Data collection is done through the Modified Ashworths Scale to evaluate the muscle tone that points to 0 to 4 for the patient's examination.
2
Description
power of muscle
Timepoint
The beginning of the study, before and after each intervention, one month after the end of the interventions
Method of measurement
Using the MRC Score based on the range of patient's movement, the score is 0-5.
3
Description
Activity of daily living
Timepoint
The beginning of the study, before and after each intervention, one month after the end of the interventions
Method of measurement
The score for Barthel's score is 0-100 based on the patient's daily activity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes 20 traumatic brain injury patients who are eligible for the study and randomly selected. The motor cortex is determined by a coil of the 8th form of magnetic stimulation. Prior to that, the threshold of motion of the intervertebral muscles of the back of the other side is determined. The lowest single pulse intensity is tms with a stimulated motor potential of 50 millivolts, determined by EMG. The following magnetic stimulation is applied as follows: Frequency: 1 Hz / pulse number: 1500 / intensity: 90% of the motor threshold Each person receives a TMS meeting for 10 days a day.
Category
Rehabilitation
2
Description
Control group: Twenty traumatic traumatic brain injury patients who were eligible for the study were randomly selected. The control group was studied by the coil off of the sham stimulation study.