Analisys of Cortical Excitability and Motor Function of Post Stroke Patients
Analysis of Electrophysiological Markers for Sensorimotor Recovery in Post Stroke Patients
1 other identifier
observational
35
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2019
CompletedMay 6, 2020
May 1, 2020
4 months
August 8, 2018
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
sensory-motor recovery level
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
baseline
Secondary Outcomes (2)
Cortical excitabilit level
baseline
level of cortical electrical activity
baseline
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-900, Brazil
Applied Neuroscience Laboratory
Recife, Pernambuco, 50740-560, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 8, 2018
First Posted
August 13, 2018
Study Start
August 15, 2018
Primary Completion
December 20, 2018
Study Completion
March 3, 2019
Last Updated
May 6, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share