StroketmstrokeNCT00697645
Use of Deep Transcranial Magnetic Stimulation After Stroke
A study testing Deep TMS (Transcranial magnetic stimulation) and Brainsway Deep TMS in people with Stroke, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS) in treating acute ischemic stroke (stroke resulting from a blood clot in the brain). TMS was found to be effective and safe in the set up of depression. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Deep TMS (Transcranial magnetic stimulation) and Brainsway Deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Jun 2014
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the inclusion criteria.
- Diagnosis of acute ischemic stroke defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia.
- Disabling neurological deficit attributable to acute ischemic stroke.
- NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others.
- A score of at least 3 on item 6 of the NIHSS (motor score leg) pre-treatment.
- Age 18-85 years, inclusive.
- Able to sign informed consent.
Who cannot join
- Patients will be excluded from study participation for any of the following reasons:
- Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 90) assessment in this trial.
- Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2).
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
Show all 18Show fewer
- Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 16 for others.
- Evidence of acute or chronic ICH by head CT or MRI.
- CT or MRI evidence of non-vascular cause for the neurological symptoms.
- Signs of mass effect causing shift of midline structures on CT or MRI.
- Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months.
- Stroke within the past 3 months.
- Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
- Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before.
- Seizure at the onset of stroke or a history of epilepsy.
- Life expectancy less than 3 months.
- Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment.
- Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or GPIIbIIIa inhibitor outside of this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Double Blind Randomized Clinical Trial of Deep Transcranial Magnetic Stimulation After Stroke
This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS) in treating acute ischemic stroke (stroke resulting from a blood clot in the brain).
TMS was found to be effective and safe in the set up of depression. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor (BDNF). This is followed by positive effects of these growth and survival factors on neuronal sprouting, re-organization and also potentially on neurogenesis. Hence it is postulated that TMS will have a positive effect on the recovery rate and extent of recovery after stroke. Brainsway innovative project involves the development and use of deep Transcranial Magnetic Stimulation in humans to treat a host of behavioral disorders, including depression and addiction. Brainsway developed a novel coil design for stimulation of deep structures in the human brain and conducted several safety and efficacy studies and recently completed a large study (70 subjects) demonstrating effectiveness in depressive patients. Deep TMS produces directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. Consistent with animal studies using brain stimulation deep TMS of the prefrontal cortex was found to exert potent antidepressant effects on patients not previously responsive to antidepressant drugs in two different studies. Therefore, it is expected that TMS will also be safe in patients with stroke.
Read more
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves a magnetic field to obtain images of the brain.
All participants will receive standard medical and rehabilitation therapy for stroke. In addition, patients recruited for the study will receive x sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for y minutes. Sessions will begin on day 3 after stroke onset and will be given on an alternate day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from the hospital, or until day 17, whichever is earlier. Assessments will include physical examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate both the response to treatment and side effects if needed. Patients will return for a follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery rate and functional status.
- Conditions
- Stroke
- Being tested
- Deep TMS (Transcranial magnetic stimulation), Brainsway Deep TMS
- Keywords
- Stroke,, Cerebrovascular disease,, Transcranial magnetic stimulation,, rehabilitation
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep TMS (Transcranial magnetic stimulation)Device
All participants will receive standard medical and rehabilitation therapy for stroke without any restrictions. In addition, patients recruited for the study will receive 7 sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for 15 minutes and the brain will be stimulated at 10Hz. Each TMS train will contain 20 pulses (2 seconds) and the inter train interval will be 20 seconds. Each session will contain 40 trains. Sessions will begin on day 3-5 after stroke onset and will be given every day, excluding weekends, for 10 days. All deep TMS will be performed in a dedicated room under the observation of an unblinded investigator. Patients will be monitored daily until discharge from the hospital, or until the end of the treatment, whichever is earlier. All assessments will be performed by investigators blinded to the therapy group.
Brainsway Deep TMSDevice
Deep TMS applied over the motor strip
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Patients with stroke will be treated with usual stroke care and sham TMS will be applied Receives: Device: Deep TMS (Transcranial magnetic stimulation); Device: Brainsway Deep TMS |
| 2 | Experimental | Deep TMS applied over the motor strip in patients with stroke in addition to usual stroke care. Receives: Device: Brainsway Deep TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving excellent functional outcome as determined by a modified Rankin score (mRS) < 2 and Barthel index (BI) > 95 obtained at 3 months after stroke onset
Measured: 2 yeras
Secondary outcomes (3)
Safety (mortality, symptomatic ICH, asymptomatic ICH, hematological, cardiac, liver etc)
Measured: 2 years
Good neurological outcome as assessed by NIH stroke scale score at discharge < 5 or showing improvement of at least 8 points from the initial stroke score or improvement of at least 2 points on item 6 of the NIHSS (motor score leg)
Measured: 2 years
Good neurological outcome as assessed by NIH stroke scale score at 3 months < 5 or showing improvement of at least 8 points from the initial stroke score or improvement of at least 2 points on item 6 of the NIHSS (motor score leg)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionJun 2014
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 Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patietns were recruited into placebo or active treatment groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronen Leker, Hadassah Medical Organization
- Investigators
- Ronen R Leker, MD, Principal investigator, Hadassah MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697645
- Sponsor's protocol ID
- tmstroke Hadassah
- Acronym
- tmstroke
- Status last verified
- Aug 2017
- First submitted
- 12 Jun 2008
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double Blind Randomized Clinical Trial of Deep Transcranial Magnetic Stimulation After Stroke
- ClinicalTrials.gov ID
- NCT00697645
- Acronym / sponsor ID
- tmstroke / tmstroke Hadassah
- Conditions
- Stroke
- Keywords
- Stroke,, Cerebrovascular disease,, Transcranial magnetic stimulation,, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Jun 2008 (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.
This study will determine the safety and efficacy of transcranial magnetic stimulation (TMS) in treating acute ischemic stroke (stroke resulting from a blood clot in the brain).
TMS was found to be effective and safe in the set up of depression. TMS acts by generating magnetic fields in the brain which simulate neuro-chemical changes and stimulate neuronal activity translating into increased secretion of growth factors such as brain derived neurotrophic factor (BDNF). This is followed by positive effects of these growth and survival factors on neuronal sprouting, re-organization and also potentially on neurogenesis. Hence it is postulated that TMS will have a positive effect on the recovery rate and extent of recovery after stroke. Brainsway innovative project involves the development and use of deep Transcranial Magnetic Stimulation in humans to treat a host of behavioral disorders, including depression and addiction. Brainsway developed a novel coil design for stimulation of deep structures in the human brain and conducted several safety and efficacy studies and recently completed a large study (70 subjects) demonstrating effectiveness in depressive patients. Deep TMS produces directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, and no need of hospitalization or anesthesia. Consistent with animal studies using brain stimulation deep TMS of the prefrontal cortex was found to exert potent antidepressant effects on patients not previously responsive to antidepressant drugs in two different studies. Therefore, it is expected that TMS will also be safe in patients with stroke.
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, rating of neurological deficits such as cognition deficits or problems walking that resulted from the stroke, and a computed tomography (CT) or a magnetic resonance (MRI) scan of the head. CT involves the use of specialized X-rays and MRI involves a magnetic field to obtain images of the brain.
All participants will receive standard medical and rehabilitation therapy for stroke. In addition, patients recruited for the study will receive x sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for y minutes. Sessions will begin on day 3 after stroke onset and will be given on an alternate day basis for 14 days (7 treatments). Patients will be monitored daily until discharge from the hospital, or until day 17, whichever is earlier. Assessments will include physical examinations and safety evaluations including blood tests to and MRI or CT scans to evaluate both the response to treatment and side effects if needed. Patients will return for a follow-up examination 30 and 90 days after treatment conclusion to evaluate their recovery rate and functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patietns were recruited into placebo or active treatment groups
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Device: Deep TMS (Transcranial magnetic stimulation), Device: Brainsway Deep TMSPatients with stroke will be treated with usual stroke care and sham TMS will be applied |
| 2 | Experimental | Device: Brainsway Deep TMSDeep TMS applied over the motor strip in patients with stroke in addition to usual stroke care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must meet all of the inclusion criteria.
- Diagnosis of acute ischemic stroke defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia.
- Disabling neurological deficit attributable to acute ischemic stroke.
- NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others.
- A score of at least 3 on item 6 of the NIHSS (motor score leg) pre-treatment.
Key exclusion criteria (18 listed)
- Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 90) assessment in this trial.
- Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2).
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
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 |
|---|---|---|
| Deep TMS (Transcranial magnetic stimulation)All participants will receive standard medical and rehabilitation therapy for stroke without any restrictions. In addition, patients recruited for the study will receive 7 sessions of TMS with the Brainsway device delivered over the motor strip of the affected hemisphere. Each session will last for 15 minutes and the brain will be stimulated at 10Hz. Each TMS train will contain 20 pulses (2 seconds) and the inter train interval will be 20 seconds. Each session will contain 40 trains. Sessions will begin on day 3-5 after stroke onset and will be given every day, excluding weekends, for 10 days. All deep TMS will be performed in a dedicated room under the observation of an unblinded investigator. Patients will be monitored daily until discharge from the hospital, or until the end of the treatment, whichever is earlier. All assessments will be performed by investigators blinded to the therapy group. | Device | 1 |
| Brainsway Deep TMSDeep TMS applied over the motor strip | Device | 1, 2 |
Primary outcome
Proportion of patients achieving excellent functional outcome as determined by a modified Rankin score (mRS) < 2 and Barthel index (BI) > 95 obtained at 3 months after stroke onset
Time frame: 2 yeras
3 secondary outcomes
Safety (mortality, symptomatic ICH, asymptomatic ICH, hematological, cardiac, liver etc)
Time frame: 2 years
Good neurological outcome as assessed by NIH stroke scale score at discharge < 5 or showing improvement of at least 8 points from the initial stroke score or improvement of at least 2 points on item 6 of the NIHSS (motor score leg)
Time frame: 2 years
Good neurological outcome as assessed by NIH stroke scale score at 3 months < 5 or showing improvement of at least 8 points from the initial stroke score or improvement of at least 2 points on item 6 of the NIHSS (motor score leg)
Time frame: 2 years
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 9 Aug 2017.
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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.
Ronen R Leker, MD principal investigator
Hadassah MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep TMS (Transcranial magnetic stimulation) and Brainsway Deep TMS in people with Stroke, run by Hadassah Medical Organization at 1 site in Israel.
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 7 inclusion and 18 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 9 Aug 2017. 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 Israel. 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.
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?
Proportion of patients achieving excellent functional outcome as determined by a modified Rankin score (mRS) < 2 and Barthel index (BI) > 95 obtained at 3 months after stroke onset (time frame: 2 yeras). 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 9 Aug 2017.