UNKNOWNNA

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

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).

Sponsor

Universidade Federal de Pernambuco

Enrollment

40 participants

Sites

2 locations

Start Date

July 2017

Completion

September 2018

StrokeTranscranial Magnetic Stimulationconventional sensory therapy

Enrollment & Timeline

UNKNOWN

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

2.1 years

total trial span

Rate

pts/month needed

Jul 2017Month 111 of 25Sep 2018

100% of trial timeline elapsed

At 2 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Somatosensory Cortex Repetitive Transcranial Magnetic Stimulation and Associative Sensory Stimulation of Peripheral Nerves Could Assist Motor and Sensory Recovery After Stroke.

de Freitas Zanona Aristela, Romeiro da Silva Andressa Claudia, do Rego Maciel Adriana Baltar et al.Frontiers in human neuroscience2024

DOI PubMed

Sensory and motor cortical excitability changes induced by rTMS and sensory stimulation in stroke: A randomized clinical trial.

de Freitas Zanona Aristela, Romeiro da Silva Andressa Claudia, Baltar do Rego Maciel Adriana et al.Frontiers in neuroscience2023

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

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Fetching protocol from ClinicalTrials.gov…

UNKNOWNNA

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

Sponsor

Universidade Federal de Pernambuco

Enrollment

40 participants

Sites

2 locations

Start Date

July 2017

Completion

September 2018

StrokeTranscranial Magnetic Stimulationconventional sensory therapy

Enrollment & Timeline

UNKNOWN

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

2.1 years

total trial span

Rate

pts/month needed

Jul 2017Month 111 of 25Sep 2018

100% of trial timeline elapsed

At 2 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Somatosensory Cortex Repetitive Transcranial Magnetic Stimulation and Associative Sensory Stimulation of Peripheral Nerves Could Assist Motor and Sensory Recovery After Stroke.

de Freitas Zanona Aristela, Romeiro da Silva Andressa Claudia, do Rego Maciel Adriana Baltar et al.Frontiers in human neuroscience2024

DOI PubMed

Sensory and motor cortical excitability changes induced by rTMS and sensory stimulation in stroke: A randomized clinical trial.

de Freitas Zanona Aristela, Romeiro da Silva Andressa Claudia, Baltar do Rego Maciel Adriana et al.Frontiers in neuroscience2023

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

change from Fugl-Meyer assessment

baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.

The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applied within clinical and in research contexts to determine the disease severity, describe motor recovery, and plan and assess interventions. In the present study, the 33-item of the UL section was employed. The items are rated on 3-point ordinal scale, as follows: 0= unable to perform; 1= partial ability to perform; and 2= near normal ability to perform. The UL subscale evaluates motor function recovery in six domains: flexor and extensor synergies, non-synergic movements, wrist and hand movements, and coordination and speed

change from The Jebsen-Taylor

baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week

The Jebsen-Taylor manual function test will be used to assess motor function . This test consists of seven tasks: writing a sentence, turning cards and small common objects, feeding simulation, stacking chips, moving large light objects and large heavy objects. Each task will be timed by the Timer, the test will be done bilaterally, always starting with the healthy hand. Patient errors will also be recorded in numbers in case of misspelled words, for example; Changes in strategy to turn cards; Dropping small objects, beans, checkers or cans.

change from The Motor Activity Long (MAL)

baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.

The Motor Activity Long (MAL) test, validated and adapted to the Portuguese language, takes into account the patient's "learning to not use" upper limb (MAS) and the functional reacquisition of arm and hand skills in daily activities. The test has two ordinal scales, each with six points for the graduation of activities: one scale relates to quantity and the other to the quality of MSA use. On the quantitative scale, scores range from zero (do not use the MSA) to five (use the MSA the same way you used before the stroke). On the qualitative scale, the score also ranges from zero (the MSA is not used at all for the activity) to five (your ability to use the MSA is as good as it was before the stroke). In this qualitative section the score can have intermediate scores as 0.5 or 1.5.

change from The Box and Blocks test (TBB)

baseline; post-intervention. The re-evaluation will be in the eleventh session on the fourth week.

The Box and Blocks test (TBB) is an instrument commonly used in manual dexterity investigations, it can be used in post-stroke patients. At TBB, one hundred and fifty blocks of 2.5-cm wood are arranged in a wooden box in many different orientations. The place in wood has a partition of 15.2 cm of height dividing the space in two. The patient is instructed to carry as many blocks as possible from one space to another. The subject's score is equal to the number of those blocks transported in a partition in one minute. The more blocks transported the better the patient's manual dexterity

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

all

Healthy Volunteers

View full 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.

Ask AI

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (2)