Repetitive Transcranial Magnetic Stimulation for "Voices"
NCT ID: NCT00004980
Last Updated: 2013-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
1999-12-31
2005-06-30
Brief Summary
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I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
Detailed Description
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Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.
Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.
This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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active rTMS
1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
repetitive transcranial magnetic stimulation (rTMS)
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
sham stimulation
Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)
sham stimulation
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Interventions
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repetitive transcranial magnetic stimulation (rTMS)
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
sham stimulation
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
* Right-handed
* At least 4 weeks on stable antipsychotic medication
Exclusion Criteria
* history of epilepsy in first degree relatives
* estimated IQ less than 80
* unable to provide informed consent
* significant unstable medical condition
* current treatment with clozapine or bupropion
* cochlear implants or other metal in the head (surgical, etc.)
* history of cardiac arrhythmia
* cardiac pacemaker
* active drug or alcohol abuse within prior 6 weeks
* pregnancy
18 Years
60 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Ralph Hoffman
Role: STUDY_CHAIR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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References
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Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104. doi: 10.1016/j.biopsych.2005.03.041.
Other Identifiers
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YALESM-9281
Identifier Type: -
Identifier Source: secondary_id
199/14809
Identifier Type: -
Identifier Source: secondary_id
A5-ETPD
Identifier Type: -
Identifier Source: secondary_id