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Analisys of Cortical Excitability and Motor Function of Post Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627364
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

Brief Summary:
Healthy individuals, after reading and signing the free and informed consent will be submitted to a single session to obtain the normal neurophysiological measures and thus compare with those obtained in individuals with PD. Healthy and post stroke patients will be submitted to a neurophysiological evaluation through transcranial magnetic stimulation (TMS) and electroencephalography (EEG). The post stroke patients will also performed the evaluation trought the fugl meyer scale.

Condition or disease
Stroke Motor Function Cortical Excitability

Detailed Description:

Fugl Meyer assesment is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. The investigators will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points.

Cortical excitability level it will be evaluated through single pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia). Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA). For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the right primary motor cortex of lesioned and non lesioned hemisphere (C3 and/or C4 - 10/20 System). After, motor evoked potential will be evaluet by 20 pulses firing with 120% of RMT.

EEG Patients will perform an assessment of brain activity through the EEG. Initially, patients will be placed seated in a chair at 90cm in front of a computer. Then, the equipment will be assembled, the points according to the 10-20 marking system will be identified: Cz, C3, C4, F3, F4, P3, P4, Fz and Pz.

The protocol will follow the sequence of six consecutive moments (1 minute each) to monitor the patient's brain activity through Neuro Spectrum software:

  1. 1st minute: REST: the patient will be relaxed, at rest, without any communication and with eyes open;
  2. 2nd minute: OBSERVE - the patient will observe the video of the movement hand to mouth;
  3. 3rd minute: EXECUTION - the patient will reproduce the movement of the video with healthy limb (post stroke patient)/ dominant hand (healthy);
  4. 4th minute: IMAGINATION - the patient will imagine the previous movement;
  5. 5th minute: EXECUTION - the patient will reproduce the movement of the video with a paretic limb (post stroke patient)/ non dominant hand (healthy);
  6. 6th minute: IMAGINATION - the patient will imagine the previous movement;

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Analysis of Electrophysiological Markers for Sensorimotor Recovery in Post Stroke Patients
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : March 3, 2019

Group/Cohort
Post stroke patients
will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in healthy individuals.
Control group
will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in post stroke patients.



Primary Outcome Measures :
  1. sensory-motor recovery level [ Time Frame: baseline ]
    Fugl Meyer assesment of paretic upper limb motor function is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points


Secondary Outcome Measures :
  1. Cortical excitabilit level [ Time Frame: baseline ]
    it will be evaluated through single pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia). Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA). For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the right primary motor cortex of lesioned and non lesioned hemisphere (C3 and/or C4 - 10/20 System). After, motor evoked potential will be evaluet by 20 pulses firing with 120% of RMT

  2. level of cortical electrical activity [ Time Frame: baseline ]

    Patients will perform an assessment of brain activity through the EEG. Initially, patients will be placed seated in a chair at 90cm in front of a computer. Then, the equipment will be assembled, the points according to the 10-20 marking system will be identified: Cz, C3, C4, F3, F4, P3, P4, Fz and Pz.

    The protocol will follow the sequence of six consecutive moments (1 minute each) to monitor the patient's brain activity through Neuro Spectrum software.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population study was composite for patients post-stroke with auditory major that 3 months and found in the eligibility criteria. In addition, it will rely on babies with health or neurological disorders.
Criteria

Inclusion Criteria:

  • Post stroke patients

    • Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging

  • Chronic Stroke (> 3 months)

    • Sensorimotor sequelae in an upper limb due to stroke
    • Score ≥ 18 at Folstein Mini Mental State Examination Healthy Subjects
    • Ages: 40 years or greater
    • Gender: Both
    • Subjects who do not have self-report of neurological or articular disorder

Exclusion Criteria:

  • Post stroke patients

    • Prior neurological diseases
    • Multiple brain lesions
    • Metal implant in the skull and face
    • Pacemaker
    • History of seizures
    • Epilepsy
    • Pregnancy
    • Hemodynamic instability
    • Traumatic orthopedic injuries of upper limb that compromise the function
    • Altered medication for less than 3 months or who underwent botulinum toxin for less than 6 months
    • Performing physical therapy elsewhere during the period of intervention Healthy Subjects
    • Pregnant women;
    • Pacemaker;
    • History of seizures;
    • Metallic implants in the head;
    • Patients with clinical evidence of brain injuries;
    • Chronic pain associated to other diseases;
    • Use of neuroleptic medications
    • Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627364


Locations
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Brazil
Applied Neuroscience Laboratory
Recife, Pernambuco, Brazil, 50740-560
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, PE, Brazil, 50670-900
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Responsible Party: Kátia Monte-Silva, Principal investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03627364    
Other Study ID Numbers: motor function_stroke
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases