StrokeNCT03627364
Analisys of Cortical Excitability and Motor Function of Post Stroke Patients
An observational study of Stroke and Motor Function, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Motor Function, Cortical Excitability
- How many people
- 35 participants
- Where
- 2 sitesBrazil
- Study dates
- 15 Aug 2018to 3 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Post stroke patients
- Prior neurological diseases
- Multiple brain lesions
- Metal implant in the skull and face
- Pacemaker
- History of seizures
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-900
Applied Neuroscience Laboratory
Recife, Pernambuco, 50740-560
About this study
Official title: Analysis of Electrophysiological Markers for Sensorimotor Recovery in Post Stroke Patients
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.
Read the 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:
- 1st minute: REST: the patient will be relaxed, at rest, without any communication and with eyes open;
- 2nd minute: OBSERVE - the patient will observe the video of the movement hand to mouth;
- 3rd minute: EXECUTION - the patient will reproduce the movement of the video with healthy limb (post stroke patient)/ dominant hand (healthy);
- 4th minute: IMAGINATION - the patient will imagine the previous movement;
- 5th minute: EXECUTION - the patient will reproduce the movement of the video with a paretic limb (post stroke patient)/ non dominant hand (healthy);
- 6th minute: IMAGINATION - the patient will imagine the previous movement;
- Conditions
- Stroke, Motor Function, Cortical Excitability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (2)
Cortical excitabilit 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
Measured: baseline
level of cortical electrical activity
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start15 Aug 2018
- Primary completion20 Dec 2018
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627364
- Sponsor's protocol ID
- motor function_stroke
- Status last verified
- May 2020
- First submitted
- 8 Aug 2018
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Electrophysiological Markers for Sensorimotor Recovery in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT03627364
- Acronym / sponsor ID
- motor function_stroke
- Conditions
- Stroke, Motor Function, Cortical Excitability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 1st minute: REST: the patient will be relaxed, at rest, without any communication and with eyes open;
- 2nd minute: OBSERVE - the patient will observe the video of the movement hand to mouth;
- 3rd minute: EXECUTION - the patient will reproduce the movement of the video with healthy limb (post stroke patient)/ dominant hand (healthy);
- 4th minute: IMAGINATION - the patient will imagine the previous movement;
- 5th minute: EXECUTION - the patient will reproduce the movement of the video with a paretic limb (post stroke patient)/ non dominant hand (healthy);
- 6th minute: IMAGINATION - the patient will imagine the previous movement;
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Post stroke patients
- Chronic Stroke (> 3 months)
Key exclusion criteria (20 listed)
- Post stroke patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Cortical excitabilit level
Time frame: baseline
level of cortical electrical activity
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Motor Function, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory-motor recovery level (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.