Clinical trial NCT03481179: Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Keywords: Repetitive transcranial magnetic stimulation, Physiotherapy, Stroke, Spasticity
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Spasticity
timeFrame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Secondary outcomes:
measure: Cortical excitability
timeFrame: before and after 10 daily sessions and after 30 days
measure: Variation of the median nerve Hmax / Mmax ratio
timeFrame: before and after 10 sessions and after 30 days
measure: Sensory-motor function of the upper limb
timeFrame: before and after 10 daily sessions and after 30 days
measure: Quality of life
timeFrame: before and after 10 daily sessions and after 30 days
measure: Qualitative and quantitative of moviment
timeFrame: before and after 10 daily sessions and after 30 days
measure: Dynamometry
timeFrame: before and after 10 daily sessions and after 30 days
measure: Changes on Patient Global Impression of Change Scale
timeFrame: before and after 10 daily sessions and after 30 days
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory
state: Pernambuco
Study officials:
affiliation: Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
name: Kátia Monte-Silva, PhD
role: STUDY_DIRECTOR
References: