Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations
Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations
This study will evaluate the long-term effects of repetitive transcranial magnetic
 stimulation (rTMS) in patients with auditory hallucinations.
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.
Inclusion Criteria:

 -  Have persistent auditory hallucinations

 Exclusion Criteria:

 -  History of neurological disorder

 -  Serious, unstable medical conditions (persons with hypertension or diabetes mellitus
 may enroll if these conditions are treated and stable)

 -  Active drug or alcohol abuse (persons may enroll if they have a history of drug or
 alcohol abuse provided that they do not use these substances at least 4 weeks prior to
 study initiation)

 -  History of seizures unrelated to drug withdrawal

 -  Estimated IQ less than 80

 -  Have a sibling or parent with epilepsy

 -  Disorganized thought process or intellectual impairment that inhibits the ability to
 give an informed consent