Clinical Trial: Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: TMS Intervention Development for Auditory Hallucinations

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

Detailed Summary:

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
Sponsor: Yale University

Current Primary Outcome: Hallucination Change Score [ Time Frame: 2 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

  • Total AHRS score [ Time Frame: 2 weeks ]
  • CGI [ Time Frame: 2 weeks ]
  • Frequency subscale of AHRS [ Time Frame: 2 weeks ]


Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: July 24, 2002
Date Started: July 2002
Date Completion:
Last Updated: August 2, 2013
Last Verified: August 2013