Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations
Condition: Schizophrenia; Hallucinations
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      This study will evaluate the long-term effects of repetitive transcranial magnetic
      stimulation (rTMS) in patients with auditory hallucinations.
    

Detailed description: 
      Auditory hallucinations can cause distress, functional disability, and problems in
      controlling behavior. In addition, auditory hallucinations are often resistant to drug
      treatment. Brain imaging studies suggest that voices arise from parts of the brain that are
      ordinarily involved in perceiving spoken speech. In TMS, an electromagnet placed on the scalp
      produces magnetic pulses that pass through the skull and stimulate the underlying cerebral
      cortex (a part of the brain). Low frequency (once per second) TMS is known to reduce
      reactivity or excitability of the part of the brain directly stimulated without damaging
      brain tissue. This study will determine if low frequency rTMS directed to brain areas
      responsible for speech processing can be used as an alternative treatment for auditory
      hallucinations and other related psychotic symptoms.

      Before starting rTMS, patients will undergo: (1) a medical and psychiatric evaluation, (2)
      neuropsychological tests to assess concentration and memory abilities, and (3) an fMRI brain
      scan (which takes about 1 ¼ hours and does not require any injections). After these
      evaluations are completed, patients will be randomly assigned (e.g., by the flip of a coin)
      to receive either low frequency rTMS or placebo stimulation for 16 minutes per day over a
      10-day period. During this time, the patient will not know whether (s)he is receiving the
      real or the placebo stimulation. For 5 days, stimulation will be administered to an area of
      the left temporal lobe of the brain that is involved in perceiving speech. This area is
      called Wernicke's area. For another 5-day period, a similar area on the right side of the
      brain will be stimulated. After the 10-day trial is completed, the patient will be told if
      (s)he received real or placebo TMS. If the patient received real TMS and experienced
      significant improvement in "voices", (s)he can choose to receive more stimulation to that
      part of the brain that produced greater improvement. If the patient has received only placebo
      stimulation, (s)he will then be offered a trial of real rTMS.

      TMS is generally not painful, but can be uncomfortable due to a tingling or knocking
      sensation and/or contraction of scalp and facial muscles. There is a small risk of seizure
      associated with TMS, but for the frequency of stimulation used in this study (1 stimulation
      per second), this risk is significant only for patients who have a prior history of seizures,
      epilepsy, or other neurological problem. We have given TMS to more than 90 persons with
      schizophrenia and auditory hallucinations and have not had a case of seizure. We are also
      concerned that TMS may cause memory or concentration problems. Therefore, we carefully
      monitor patients for early signs of such difficulties, using daily questionnaire assessments
      and weekly neuropsychological tests. If we suspect that a patient is experiencing problems
      with memory or concentration, the trial is stopped. A small percentage of patients in our
      previous studies (less than 5%) reported problems with memory that ended soon after the trial
      was stopped.
    

Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): 1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Auditory hallucinations (voices)