Treatment of Bipolar Depression With H1-Coil Deep Brain rTMS: Clinical-Cognitive and Safety Evaluation
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers
      are partially effective in the treatment of depressive phase of the illness, although there
      are some reports relating to the antidepressant properties of these drugs. Other conventional
      methods (pharmacological) and non- conventional treatment are not effective or involve risks
      and side effects. Several studies with Transcranial Magnetic Stimulation (TMS) showed that
      magnetic stimulation daily over the left prefrontal cortex may improve the mood of patients.
      TMS is a noninvasive method of stimulating the brain. The instrument used nowadays in local
      research and application Clinical is a metallic coil formed in figure 8 (coil format 8). This
      instrument was capable of stimulating only surface areas of the brain, primarily the cerebral
      cortex, at depths of up to 3 inches below the scalp. From this angle, there is clearly a need
      for a means of producing magnetic fields which can reach deeper brain areas, such as those
      involved in mood disorders. TMS has little, if any effect in these brain areas. To this end,
      new coils, calls "H", that promote the stimulation of deep brain areas were developed in
      collaboration with the National Institute of Health (NIH) in the USA. This new coil - H1 that
      will be evaluated in this study has been tested for safety in NIH in 2003 by Dr. Abraham
      Zangen. Yet there are very few prospective clinical, randomized and controlled trials, on the
      effects of early and late in clinical-cognitive condition and safety of TMS with H1 coils in
      treating episodes of bipolar depression. The application of EMT with H1 coils can reach
      deepest regions of the brain and improve the clinical and cognitive condition of subjects
      with episodes of bipolar depression, and may be confirmed as a safe and virtually free of
      side effects. By an absence of treatment actually effective for bipolar depression, this
      study will show whether there are clinical and cognitive benefits of deep TMS with H1 coil in
      patients with bipolar depression.
    

Detailed description: 
      The present research protocol will evaluate clinical-cognitive and safety effects of H1-Coil
      Deep Brain Transcranial Magnetic Stimulation over prefrontal cortex in subjects with bipolar
      depression, currently treated with mood stabilizer and/or antipsychotics for stabilization
      and sleep regulation. Patients will be clinically evaluated with the Diagnostic and
      Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria for Bipolar Depressive
      Episode. Symptoms intensity will be rated according to The Hamilton Depression Scale (HAMD
      -17 items) - main outcome. Patients with scores higher than 18 will be included and the
      cognitives functions will be evaluated according with tasks of neuropsychologic battery
      chosen. Patients with active neurological or severe disorders (such as cancer, auto-imune and
      cardiologic disorders) will be excluded. The present study is a double-blinded, controlled,
      randomized trial with 50 patients in bipolar depression episode. The intervention protocol
      consist in 20 consecutive daily deep TMS sessions (skipping the weekend). After meeting
      eligibility criteria, patients will be randomized (computer generated list) to one of the two
      intervention groups: 25 patients in Active H1-Coil deep brain rTMS group and Sham H1-Coil
      deep brain rTMS group. H1-Coil deep brain rTMS sessions will follow the following steps: the
      first day of treatment, patients will be instructed to wear earplugs to minimize the risk of
      impaired hearing. Then, the threshold intensity of stimulation motor is determined by
      applying pulses only to the motor cortex. The stimulation threshold is determined pro
      gradually increase the stimulation intensity every 5 seconds. The stimulation threshold is
      defined as stimulation of lesser intensity that can evoked motor potential with at least 50μV
      amplitude of at least 5 tentativas.A coil is positioned to 5 centimeters below the hot spot
      (in the prefrontal area) intensity - 120% of the threshold engine. Each session will receive
      55 groups of stimuli, duration - 2/2 , frequency - 18 Hz , area - left prefrontal , intervals
      - 20 seconds . Soon, 1,980 pulses of magnetic stimulation will be administered every day (per
      session), totaling 39,600 pulses throughout treatment. Patients will be clinically assessed
      at baseline, weekly during the four weeks of treatment and for four weeks after completion of
      treatment ending in 8 weeks. Main outcome will be based on HAMD-17 items at a endpoint of
      4-weeks and follow up 4-weeks, with secondary outcomes assessing Young Mania Rating Scale (11
      items) at 8 weeks. Other evaluation scales include, Hamilton Anxiety Scale, Global Assessment
      Scale and Clinical Global Impression at 8 weeks. The cognitive assessment will be performed
      with a neuropsychologic battery tests at baseline, endpoint of 4-weeks and endpoint of
      8-weeks with a trained neuropsychologist. Also a Safety Deep rTMS Scale, adverse effects
      scales and clinical evaluation with a trained physician.
    

Intervention name(s): Deep Brain Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): H1-Coil deep brain rTMS at cortex prefrontal.
Other intervention name(s): H1-Coil deep brain rTMS;; H1-Coil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Deep Brain Transcranial Magnetic Stimulation;; H1-Coil deep brain rTMS;; H1-Coil;; Bipolar Depression;; Cognition.