Use of Deep Transcranial Magnetic Stimulation After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    


Intervention name(s): Deep TMS (Transcranial magnetic stimulation); Brainsway Deep TMS
Intervention type(s): Device; Device
Intervention description(s): 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.; Deep TMS applied over the motor strip
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patietns were recruited into placebo or active treatment groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke,; Cerebrovascular disease,; Transcranial magnetic stimulation,; rehabilitation