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

Universidade Federal de Pernambuco

Status: Unknown

Conditions: Chronic Stroke

Treatments: Other: Physical therapy; Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03481179

Stroke_High_rTMS

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Experimental: hf rTMS and Physical therapy

Experimental group

Description:

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.

Treatment:

Device: TMS

Other: Physical therapy

Control: Sham hf rTMS and Physical theraphy

Sham Comparator group

Description:

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.

Treatment:

Device: TMS

Other: Physical therapy