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

NCT ID: NCT03481179

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-04-30

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.

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

TMS

Intervention Type: DEVICE

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.

Physical therapy

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

TMS

Intervention Type: DEVICE

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.

Physical therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Other Intervention Names

non invasive brain stimulation, high frequency rTMS

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Kátia Monte-Silva

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kátia Monte-Silva, PhD

Role: STUDY_DIRECTOR

Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

Locations

Applied Neuroscience Laboratory

Recife, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Kátia Monte-Silva, PhD

Role: CONTACT

monte.silvakk@gmail.com

+55 81 988631322

Camilla Sales, PT

Role: CONTACT

millbasales@gmail.com

+55 81 997299255

Facility Contacts

Camilla Sales, PT

Role: primary

millabsales@gmail.com

Rebeca Dias, PT

Role: backup

Other Identifiers

Stroke_High_rTMS

Identifier Type: -

Identifier Source: org_study_id