StrokePhase 4NTMSRNCT01652677
Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation
A Phase 4 study testing Transcranial magnetic stimulation in people with Stroke, run by Russian Academy of Medical Sciences at 2 sites in Russia.
Trial summary
The aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesRussia
- Study dates
- Jan 2012to Dec 2014
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a person with confirmed cerebral blood flow by ischemic from 8 days to 3 years in a pool of carotid arteries;
- Persons with acute cerebrovascular accidents related to the severity of stroke scale NIHSS (National Institute of Health Stroke Scale) from 5 to 20 points;
- People with cerebral circulatory assessment on the modified Rankin scale at most 3;
- the availability of informed consent;
- healthy volunteers who gave informed consent to participate in the study.
Who cannot join
- The presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
- The plight of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, myocardial infarction, venous thrombosis of lower extremities, episodes of pulmonary embolism;
- The severity of neurological deficit, which does not allow the patient to pass on their own 10 meters (you can use additional support);
- Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
- The presence of metallic elements or implants in the head region, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plates that cover the defects of the skull, metallic foreign body in the cranial cavity);
- Identification of epileptiform activity during the screening of EEG before the study;
Show all 15Show fewer
- Epilepsy or seizures in history;
- Patient refusal to participate in the study;
- Identified in the study of the general intolerance of the pulsed magnetic field;
- The development of inclusion in the study after acute myocardial infarction and acute cerebral circulatory disorders;
- Setting the pacemaker, intracardiac catheters, or operations on the brain, requiring the abandonment of metallic objects in the cranial cavity;
- The onset of pregnancy;
- Enhancement of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation);
- The emergence of an epileptic seizure in response to the rhythmic TMS;
- Patient refusal to continue participation in the study;
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Research center of neurology Russian academy of medical science
Moscow, 125367
Research center of neurology RAMS
Moscow, Volokolamskoe Shosse, 80, 125367
About this study
Official title: Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"
The aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol.
Read the detailed description
Stroke is the main cause of long-term disability among adults. Disability following stroke results in significant impairment of patients quality of life. There was a lot of investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional therapy in stroke rehabilitation. In this researches uses different protocols and patient's categories: high-frequency, low-frequency, etc. Using method of navigation transcranial magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess effectiveness of therapy and forming prognosis.
- Conditions
- Stroke
- Being tested
- Transcranial magnetic stimulation
- Keywords
- navigation transcranial magnetic stimulation, stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationProcedure or surgery
Also called Transcranial magnetic stimulation, brain stimulation
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
| Study group | Role | What they receive |
|---|---|---|
| Low-frequency stimulation | Experimental | Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere Receives: Procedure: Transcranial magnetic stimulation |
| High frequency stimulation | Experimental | Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere Receives: Procedure: Transcranial magnetic stimulation |
| Sham stimulation | Sham comparator | Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group) Receives: Procedure: Transcranial magnetic stimulation |
| Both hemispheric stimulation | Experimental | Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected. Receives: Procedure: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
Measured: up to 20 days
The emergence of epileptic seizure
Measured: up to 20 days
Secondary outcomes (1)
Evaluation of the clinical condition of the patient
We plan to use different scales to examine clinical condition of patient: Fugl-Meyer scale, Ashworth scale, Perry scale, test with 10 meters walking, Bartel index, Renkin scale
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chervyakov Alexander, Russian Academy of Medical Sciences
- Investigators
- Ludmila A. Chernikova, Study chair, Research center of neurology Russian academy of medical scienceMichael A Piradov, professor, Principal investigator, Research center of neurology RAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652677
- Sponsor's protocol ID
- TMS-001
- Acronym
- NTMSR
- Status last verified
- Apr 2015
- First submitted
- 28 Jun 2012
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chernikova LA, Kremneva EI, Cherviakov AV, Saenko IV, Konovalov RN, Piramidov MA, Kozlovskaia IB. [New approaches in the study of neuroplasticity process in patients with central nervous system lesion]. Fiziol Cheloveka. 2013 May-Jun;39(3):54-60. doi: 10.7868/s0131164613030053. Russian.
PubMed 23885553Mokienko OA, Chervyakov AV, Kulikova SN, Bobrov PD, Chernikova LA, Frolov AA, Piradov MA. Increased motor cortex excitability during motor imagery in brain-computer interface trained subjects. Front Comput Neurosci. 2013 Nov 22;7:168. doi: 10.3389/fncom.2013.00168. eCollection 2013.
PubMed 24319425
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"
- ClinicalTrials.gov ID
- NCT01652677
- Acronym / sponsor ID
- NTMSR / TMS-001
- Conditions
- Stroke
- Keywords
- navigation transcranial magnetic stimulation, stroke rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jul 2012 (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 aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol.
Detailed description
Stroke is the main cause of long-term disability among adults. Disability following stroke results in significant impairment of patients quality of life. There was a lot of investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional therapy in stroke rehabilitation. In this researches uses different protocols and patient's categories: high-frequency, low-frequency, etc. Using method of navigation transcranial magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess effectiveness of therapy and forming prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-frequency stimulation | Experimental | Procedure: Transcranial magnetic stimulationStimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere |
| High frequency stimulation | Experimental | Procedure: Transcranial magnetic stimulationStimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere |
| Sham stimulation | Sham comparator | Procedure: Transcranial magnetic stimulationPatients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group) |
| Both hemispheric stimulation | Experimental | Procedure: Transcranial magnetic stimulationStimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a person with confirmed cerebral blood flow by ischemic from 8 days to 3 years in a pool of carotid arteries;
- Persons with acute cerebrovascular accidents related to the severity of stroke scale NIHSS (National Institute of Health Stroke Scale) from 5 to 20 points;
- People with cerebral circulatory assessment on the modified Rankin scale at most 3;
- the availability of informed consent;
- healthy volunteers who gave informed consent to participate in the study.
Key exclusion criteria (15 listed)
- The presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
- The plight of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, myocardial infarction, venous thrombosis of lower extremities, episodes of pulmonary embolism;
- The severity of neurological deficit, which does not allow the patient to pass on their own 10 meters (you can use additional support);
- Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
- The presence of metallic elements or implants in the head region, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plates that cover the defects of the skull, metallic foreign body in the cranial cavity);
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 |
|---|---|---|
| Transcranial magnetic stimulationAlso: Transcranial magnetic stimulation, brain stimulationTranscranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields. | Procedure or surgery | Both hemispheric stimulation, High frequency stimulation, Low-frequency stimulation, Sham stimulation |
Primary outcome
Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
Time frame: up to 20 days
The emergence of epileptic seizure
Time frame: up to 20 days
1 secondary outcome
Evaluation of the clinical condition of the patient
Time frame: up to 20 days
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 1 May 2015.
- Background: PubMed 23885553Chernikova LA, Kremneva EI, Cherviakov AV, Saenko IV, Konovalov RN, Piramidov MA, Kozlovskaia IB. [New approaches in the study of neuroplasticity process in patients with central nervous system lesion]. Fiziol Cheloveka. 2013 May-Jun;39(3):54-60. doi: 10.7868/s0131164613030053. Russian.
- Results publication: PubMed 24319425Mokienko OA, Chervyakov AV, Kulikova SN, Bobrov PD, Chernikova LA, Frolov AA, Piradov MA. Increased motor cortex excitability during motor imagery in brain-computer interface trained subjects. Front Comput Neurosci. 2013 Nov 22;7:168. doi: 10.3389/fncom.2013.00168. eCollection 2013.
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.
Ludmila A. Chernikova study chair
Research center of neurology Russian academy of medical science
Michael A Piradov, professor principal investigator
Research center of neurology RAMS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcranial magnetic stimulation in people with Stroke, run by Russian Academy of Medical Sciences at 2 sites in Russia.
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 5 inclusion and 15 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 1 May 2015. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (time frame: up to 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01652677, which also lists 2 linked publications.
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 1 May 2015.