StrokeNCT02401698
Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients
An observational study of Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The past 10 years of research in post stroke patients have shown certain types of rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Functional clinical and TMS diagnostic
- How many people
- 8 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 8 a 19 patients who have suffered a unilateral ischemic stroke up to 2 years and who will undergo motor rehabilitation at the study center will be asked to participate in the study
Who may be able to join
- one sided ischemic stroke confirmed by radiology
- adults
Who cannot join
- brainstem stroke
- cerebellar stroke
- seizure with the recent stroke
- any history of uncontrolled seizure
- pregnancy or planning on getting pregnant during the next year
- recent history (past year) of alcohol and drug abuse (due to lack of follow up) Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
São Paulo, São Paulo, 05716-150
About this study
The past 10 years of research in post stroke patients have shown certain types of rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.
Read the detailed description
Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.
- Conditions
- Stroke
- Being tested
- Functional clinical and TMS diagnostic
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Neuronal Plasticity, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional clinical and TMS diagnosticOther
Functional clinical and TMS diagnostic examination to evaluate corticospinal motor tract activity and corticocerebellar tract activity and its relation with stroke recovery
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation.
To explore the relationship between the cerebellar brain inhibition - CBI and motor function of upper extremities of patients with stroke. The cerebellar brain inhibition will be assessed by Transcranial Magnetic Stimulation (TMS) and the motor function of the upper extremities by the Upper Limb Fugl-Meyer Scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: To perform a interim analyzes
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linamara Rizzo Battistella, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401698
- Sponsor's protocol ID
- 36990314.4.0000.0068
- Status last verified
- Jan 2016
- First submitted
- 26 Nov 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients
- ClinicalTrials.gov ID
- NCT02401698
- Acronym / sponsor ID
- 36990314.4.0000.0068
- Conditions
- Stroke
- Keywords
- Stroke, Transcranial Magnetic Stimulation, Neuronal Plasticity, Rehabilitation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: To perform a interim analyzes
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- 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.
The past 10 years of research in post stroke patients have shown certain types of rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.
Detailed description
Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 8 a 19 patients who have suffered a unilateral ischemic stroke up to 2 years and who will undergo motor rehabilitation at the study center will be asked to participate in the study
Key inclusion criteria (2 listed)
- one sided ischemic stroke confirmed by radiology
- adults
Key exclusion criteria (6 listed)
- brainstem stroke
- cerebellar stroke
- seizure with the recent stroke
- any history of uncontrolled seizure
- pregnancy or planning on getting pregnant during the next year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional clinical and TMS diagnosticFunctional clinical and TMS diagnostic examination to evaluate corticospinal motor tract activity and corticocerebellar tract activity and its relation with stroke recovery | Other | – |
Primary outcome
Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation.
Time frame: 3 months
To explore the relationship between the cerebellar brain inhibition - CBI and motor function of upper extremities of patients with stroke. The cerebellar brain inhibition will be assessed by Transcranial Magnetic Stimulation (TMS) and the motor function of the upper extremities by the Upper Limb Fugl-Meyer Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Linamara Rizzo Battistella, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Sao Paulo General Hospital at 1 site 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 2 inclusion and 6 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: paused, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Motor function on the Upper Limb Fugl-Meyer Scale and the motor evoked potentials (MEP) on the Transcranial Magnetic Stimulation. (time frame: 3 months). 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 11 Jan 2016.