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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481179
• Other study ID #: Stroke_High_rTMS
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2018
• Last updated: March 21, 2018
• Start date: August 1, 2017
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Universidade Federal de Pernambuco
• Contact: Kátia Monte-Silva, PhD
• Phone: +55 81 988631322
• Email: monte.silvakk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Muscle Spasticity
• Stroke

Intervention

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:
• 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

Locations

Country	Name	City	State
Brazil	Applied Neuroscience Laboratory	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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