Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients

Universidade Federal de Pernambuco

Status: Unknown

Conditions: Stroke

Treatments: Behavioral: conventional sensory therapy; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03329807

rTMS_sensory_therapy_stroke

Details and patient eligibility

About

The aim of this research will be to investigate in stroke patients whether upper limb motor function can be maximized in response to sensory stimulation by comparing protocols for the application of Transcranial Magnetic Stimulation (rTMS) in the cortical region of S1 and Sensory Therapy in the upper limb paretic. Patients will be randomly and randomly allocated into four groups, Group 1 (G1) composed of individuals who will receive the protocol for the application of rTMS in the ipsilateral S1 cortex and fictitious sensory therapy in the paretic upper limb; Group 2 (G2) subjects will receive protocol of Sensory Therapy in the upper limb ethical and application of fictitious rTMS in the ipsilesional S1 cortex; Group 3 (G3): application of the protocol of application of rTMS in the ipsilateral S1 cortex associated with Sensory Therapy in the upper limb paretic and, G4 (GSHAM) control group in which fictitious rTMS will be performed and fictitious Sensory Therapy in the paretic upper limb).

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging,
• absence of cognitive deficits (evaluated by Mini Mental State Examination, score ≥ 20 - FOLSTEIN 1975);
• partially preserved motor functions (evaluated by the Fugl-Meyer Scale, score between 14 and 60, due to the necessary movements to be performed during the intervention);
• partially preserved sensorial (evaluated by the Fugl-Meyer Scale, score between 2 and 10 in the sensorial item , Indicating subjects with sensorial alterations but without extinction of the sensation) (MAKI, QUAGLIATO, CACHO, et al., 2006);
• patients who, through exposure to electric current by TENS, perceive the electrical stimulation in the palm, back of the hand and ventral forearm will be included.

Exclusion criteria

• clinical evidence of multiple brain lesions or other associated neurological diseases;
• peripheral neuropathies;
• leprosy;
• fibromyalgia;
• rheumatoid arthritis;
• other upper and lower motor neuron pathologies;
• sensitizing skin diseases;
• history of psychiatric illnesses including drug and alcohol abuse;
• traumato-orthopedic deformities installed in upper limbs;
• those who are performing some rehabilitation treatment during the collection (Physiotherapy and / or Occupational Therapy) will not participate in the research.

In addition, for the application of rTMS:

• patients with intracranial metal implants will be excluded;
• pregnancy;
• history of seizures and / or epilepsy;
• use of medication that interferes with cortical excitability.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Experimental rTMS and conventional sensory therapy

Experimental group

Description:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS) The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 10Hz on the injured hemisphere by stroke; 1500 pulses with an intensity of 120% of MT 10 sessions of rTMS, one per day, always before conventional sensory therapy. rTMS it will be applied for about 20 minutes, five days per week. Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.

Treatment:

Device: Transcranial Magnetic Stimulation

Behavioral: conventional sensory therapy

Sham Comparator

Sham Comparator group

Description:

control The control group received rTMS sham stimulation (same area as the experimental group) in 10 sessions, 5 days per week, and Sham conventional sensory therapy in the paretic upper limb The sham stimulation will be applied so that it is perceived by the patient as real. Thus during the rTMS sessions the same procedures of the active rTMS sessions will be applied, however the stimulation will be performed with two coils: a coil coupled to the stimulator positioned away from the patient's scalp, yet not visible to the patient so that the patient Perceive only the characteristic sound of the stimulation, and the other coil, disconnected from the stimulator positioned on the volunteer's head. For the SHAM group, all sensory therapy activities will be performed, however only with the non-affected member. Patients will be convinced that a transfer of skills from one member to another can occur through the connections between the hemispheres.

Treatment:

Behavioral: conventional sensory therapy