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TMS Treatment for Patients With Persistent Auditory Hallucinations ("Voices")

This study is ongoing, but not recruiting participants.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00042159
  Purpose

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


Condition Intervention
Schizophrenia
Hallucinations
Procedure: low frequency repetitive transcranial magnetic stimulation

MedlinePlus related topics:   Schizophrenia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   TMS Intervention Development for Auditory Hallucinations

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   40
Study Start Date:   January 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042159

Locations
United States, Connecticut
Yale-New Haven Psychiatric Hospital    
      New Haven, Connecticut, United States, 06519

Sponsors and Collaborators
  More Information

Provides basic information about this and related studies conducted at Yale.  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   R21 MH63326, DSIR AT-SO
First Received:   July 24, 2002
Last Updated:   July 21, 2006
ClinicalTrials.gov Identifier:   NCT00042159
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Auditory hallucinations (voices)  

Study placed in the following topic categories:
Schizophrenia
Signs and Symptoms
Mental Disorders
Hallucinations
Neurologic Manifestations
Psychotic Disorders
Neurobehavioral Manifestations
Schizophrenia and Disorders with Psychotic Features
Perceptual Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2008




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