Clinical trial NCT03329807: Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients
Official title: Effects of Transcranial Magnetic Stimulation Associated to Sensory Therapy for Treatment of Motor Function of Upper Limb of Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 40
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: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: change from Fugl-Meyer assessment
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
measure: change from The Jebsen-Taylor
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week
measure: change from The Motor Activity Long (MAL)
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
measure: change from The Box and Blocks test (TBB)
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
Secondary outcomes:
measure: change from Thermography
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
measure: change from Upper limb cutaneous sensitivity
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
measure: change from cortical excitability
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
measure: change from Functional Independence
timeFrame: baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambucano
state: Pernambuco
city: Recife
country: Brazil
facility: Aristela de Freitas Zanona
Study officials:
References:
citation: de Freitas Zanona A, Romeiro da Silva AC, do Rego Maciel AB, Gomes do Nascimento LS, Bezerra da Silva A, Bolognini N, Monte-Silva K. Somatosensory Cortex Repetitive Transcranial Magnetic Stimulation and Associative Sensory Stimulation of Peripheral Nerves Could Assist Motor and Sensory Recovery After Stroke. Front Hum Neurosci. 2022 Apr 11;16:860965. doi: 10.3389/fnhum.2022.860965. eCollection 2022.