Use of Deep Transcranial Magnetic Stimulation After Stroke "tmstroke"

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranial Magnetic Stimulation Procedure
    Other Names: Transcranial magnetic stimulation, brain stimulation
    Intervention Desc: In this TMS study, 1 Hz (slow) repetitive TMS is used to suppress overactivity in a pre-tested cortical area of the right frontal lobe; usually the small target area is a part of the right Broca's area homologue (posterior Pars Triangularis).
  • Deep Transcranial Magnetic Stimulation (Brainsway)Procedure/Surgery
    Intervention Desc: enables non-invasive excitation or inhibition of practically any brain structure, in any deep or cortical region.
  • Deep TMS (Transcranial magnetic stimulation) Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Patients with stroke will be treated with usual stroke care and sham TMS will be applied
  • Brainsway Deep TMS Device
    Intervention Desc: Deep TMS applied over the motor strip
    ARM 1: Kind: Experimental
    Label: 1
    Description: Patients with stroke will be treated with usual stroke care and sham TMS will be applied
    ARM 2: Kind: Experimental
    Label: 2
    Description: Deep TMS applied over the motor strip in patients with stroke in addition to usual stroke care.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.
Secondary Safety (mortality, symptomatic ICH, asymptomatic ICH, hematological, cardiac, liver etc); 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); 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).
Primary 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 2 yeras No
Secondary Safety (mortality, symptomatic ICH, asymptomatic ICH, hematological, cardiac, liver etc) 2 years Yes
Secondary 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) 2 years No
Secondary 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) 2 years No

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