Electric And Magnetic Fields |
Cell Phones; Electromagnetic Fields; EMF |
Clinical Trial: Randomized Study of Repetitive Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
Randomized Study of Repetitive Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
This study is currently recruiting patients.
|
Purpose
OBJECTIVES: I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
| Condition | Treatment or Intervention |
|---|---|
| Schizophrenia | Procedure: transcranial magnetic stimulation |
MedlinePlus related topics: Schizophrenia
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 60
Study start: December 1999
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of four treatment arms. Arm I: Patients receive 9 days of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS on day 1, 12 minutes duration on day 2, and 16 minutes duration on days 3-9. The total duration of stimulation is 132 minutes. Arm II: Patients receive 9 days of sham rTMS. Patients are then offered active rTMS for the same length of time. Arm III: Patients receive 5 days of active rTMS which consists of 8 minutes of rTMS on day 1, 12 minutes duration on day 2, and 16 minutes on days 3-5. The total duration of stimulation is 68 minutes. Arm IV: Patients receive 5 days of sham rTMS. Patients are then offered active rTMS for the same length of time. Patients are followed weekly for 3 months.
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
- Auditory hallucinations occurring at least 5 times per day resistant to adequate medication trials of at least 2 alternative antipsychotic medications, including at least 1 atypical agent Adequate medication trial defined as at least 6 weeks at a dose of 1000 CPZ equivalents for standard neuroleptics and published recommendations of therapeutic dosing for atypical neuroleptics
- Righthanded
- No history of seizure that is not drug induced or secondary to alcohol withdrawal
- No first degree relative with epilepsy
--Prior/Concurrent Therapy--
- At least 2 weeks on stable antipsychotic medication No concurrent clozapine or bupropion No cochlear implants or surgically implanted metal implants in the head
--Patient Characteristics--
- Cardiovascular: No history of cardiac arrhythmia No cardiac pacemaker
- Other: No active drug or alcohol abuse within past 6 weeks No serious medical illness that would increase risk to patient in case of seizure No shrapnel in the head Not pregnant Negative pregnancy test
Location and Contact Information
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520-8035, United States; Recruiting
Ralph Hoffman, Study Chair, Yale University
More Information
Record last reviewed: December 2003
Last Updated: October 13, 2004
Record first received: March 10, 2000
ClinicalTrials.gov Identifier: NCT00004980
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Electric And Magnetic Fields (National Women's Health Information Center)
- EMF (Electric and Magnetic Fields): Questions and Answers (National Institute of Environmental Health Sciences)

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