Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients

Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical

In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.

Study Overview

• Status: Unknown
• Conditions: Chronic Stroke
• Intervention / Treatment: Device: TMS; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-560
      • Recruiting
      • Applied Neuroscience Laboratory
      • Contact: Camilla Sales, PT; Email: millabsales@gmail.com
      • Contact: Rebeca Dias, PT
      • Principal Investigator: Kátia K Monte-Silva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 30 to 75 years;
• Both sexes;
• With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
• Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON & SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
• With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)

Exclusion Criteria:

• Contraindications to and EMT (ROSSINI et al., 2015)
• Clinical evidence of multiple brain lesions
• Trauma-orthopedic injury that limits the range of motion of the upper limb
• Presence of visual and / or communication deficit
• Involvement of other interventions focused on reducing spasticity
• Modification of medications in the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: hf rTMS and Physical therapy; High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.	Device: TMS; Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.; Other Names: non invasive brain stimulation, high frequency rTMS; Other: Physical therapy; The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM & JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient
Sham Comparator: Control: Sham hf rTMS and Physical theraphy; In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.	Device: TMS; Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.; Other Names: non invasive brain stimulation, high frequency rTMS; Other: Physical therapy; The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM & JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity	Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.	before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical excitability	Expressed as percent motor resting threshold and numerical values of motor evoked potential. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).	before and after 10 daily sessions and after 30 days
Variation of the median nerve Hmax / Mmax ratio	The reflex H is an estimate of the excitability of the alpha motoneuron when there is a pre-synaptic inhibition (PALIERI, R.M et al., 2004). The variation of the H-reflex amplitude will evaluate the spinal cord excitability variation.	before and after 10 sessions and after 30 days
Sensory-motor function of the upper limb	This consists of a quantitative scale developed to measure the recovery of the motor function of stroke patients.Measured through the Fugl-Meyer Rating Scale. Expressed in values from 0 to 66;	before and after 10 daily sessions and after 30 days
Quality of life	Expressed in numerical values for each domain, the SSQOL has 49 items distributed in 12 domains (energy, family role, language, mobility, humor, personality, self-care, social role, reasoning, upper limb function, vision and work / productivity). There are three possibilities for responses that are quantified on a five-to-one scale.	before and after 10 daily sessions and after 30 days
Qualitative and quantitative of moviment	Motor Activity Log 30 (MAL-30) is a standardized instrument that was developed specifically to evaluate the function and use of the upper limb most affected post-stroke in the real-life environment (uncontrolled) through two scales: qualitative and quantitative. The total score is obtained by calculating the mean for each of the scales. The higher the mean obtained in the scales, the better the quality and quantity of use of the upper limb more affected in the accomplishment of the daily activities of life.	before and after 10 daily sessions and after 30 days
Dynamometry	It consists of an objective and quantitative way of measuring muscle shape using a manual portable dynamometer. The test will be performed with the Jamar dynamometer in KGF.	before and after 10 daily sessions and after 30 days
Changes on Patient Global Impression of Change Scale	Changes on Patient Global Impression of Change Scale - (time frame: baseline, before 6 session, after 10 sessions) The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".	before and after 10 daily sessions and after 30 days

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: Stroke_High_rTMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No