Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations
Condition: Schizophrenia and Related Disorders
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      The Repetitive Transcranial Magnetic Stimulation (rTMS) is a type of brain stimulation that
      uses a magnet to change activity in the brain. rTMS uses magnetic pulses to induce an
      electrical current in the brain to alter brain activity and function in specific areas. For
      example, stimulating the part of the brain controlling movement will cause parts of the foot
      or leg to twitch. TMS is proposed as a novel treatment for people with schizophrenia. The
      investigators want to see if low frequency rTMS can lessen some of the symptoms of
      schizophrenia, specifically auditory verbal hallucinations. Auditory verbal hallucinations
      describe the experience of hearing voices that are not really there.
    

Detailed description: 
      The large majority of patients with schizophrenia (Sz) experience auditory verbal
      hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal
      hallucinations (AVH) affect a third of patients with schizophrenia and can cause increased
      aggression, distress, suicide, and social dysfunction. The current standard of care is
      antipsychotic medication which can cause metabolic syndrome, sedation, orthostatic
      hypotension, extrapyramidal symptoms, and tardive dyskinesia among other adverse effects.
      Transcranial magnetic stimulation (TMS) emits a rapidly changing magnetic field over the
      scalp which induces current flow in underling brain tissue, either enhancing or disrupting
      function depending on the frequency of stimulation. It is generally well tolerated and
      repetitive TMS (rTMS) is currently FDA approved for treatment of depression. rTMS carries
      potential as an alternative treatment for schizophrenia patients with AVH who either do not
      respond to or do not tolerate medication. Inhibitory (1-Hz) standard TMS approaches, which
      use scalp-based targeting of speech perception areas such as left temperoparietal junction
      (TPJ) have yielded mixed results in reducing AVH, possibly due to variability of underlying
      brain anatomy between individual subjects. The influence of anatomical variability could be
      eliminated by individually positioning the TMS coil according to each patient's structural
      brain MRI. The proposed pilot project will investigate the clinical efficacy of open-label
      individualized MRI-guided TMS applied to the left TPJ in ten patients with schizophrenia or
      schizoaffective disorder. If the results of the pilot study show promising reductions in AVH,
      it will set up the foundation for a larger sham-controlled clinical trial.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device
Intervention description(s): During the rTMS session, an electromagnetic coil is placed against the subjects scalp on the left side of the head. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in speech perception.
Intervention model: Single Group Assignment
Intervention model description: This is an open-label study for participants with a diagnosis of either schizophrenia or schizoaffective disorder with persistent auditory verbal hallucinations (AVH) that are eligible to have repetitive transcranial magnetic stimulation (rTMS) targeting the left temperoparietal junction (TPJ).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hallucinations; Auditory Verbal Hallucinations