Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00697645
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2008-06-12
Brief Title:
Use of Deep Transcranial Magnetic Stimulation After Stroke
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Phase 2 Double Blind Randomized Clinical Trial of Deep Transcranial Magnetic Stimulation After Stroke
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tmstroke
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None