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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ralph Edward Hoffman, Yale University
ClinicalTrials.gov Identifier:
NCT00042159
First received: July 24, 2002
Last updated: August 2, 2013
Last verified: August 2013

July 24, 2002
August 2, 2013
July 2002
July 2003   (final data collection date for primary outcome measure)
Hallucination Change Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00042159 on ClinicalTrials.gov Archive Site
  • Total AHRS score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • CGI [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Frequency subscale of AHRS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Transcranial Magnetic Stimulation (TMS) Treatment for Patients With Persistent Auditory Hallucinations
TMS Intervention Development for 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Hallucinations
Device: repetitive transcranial magnetic stimulation
1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2004
July 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042159
R21 MH63326, R21MH063326, DSIR AT-SO
Yes
Ralph Edward Hoffman, Yale University
Yale University
National Institute of Mental Health (NIMH)
Not Provided
Yale University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP