Clinical Trials Directory

Trials / Completed

CompletedNCT03627364

Analisys of Cortical Excitability and Motor Function of Post Stroke Patients

Analysis of Electrophysiological Markers for Sensorimotor Recovery in Post Stroke Patients

Status
Completed
Phase
Study type
Observational
Enrollment
35 (actual)
Sponsor
Universidade Federal de Pernambuco · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

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;

Conditions

Timeline

Start date
2018-08-15
Primary completion
2018-12-20
Completion
2019-03-03
First posted
2018-08-13
Last updated
2020-05-06

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03627364. Inclusion in this directory is not an endorsement.