Clinical trial NCT00004980: Repetitive Transcranial Magnetic Stimulation for "Voices"
Official title: Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: neurologic and psychiatric disorders
rare disease
schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2000-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.

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

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Inclusion criteria:

* Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
* 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 seizure (unless due to drug withdrawal or medication that is no longer prescribed)
* 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

Primary outcomes:
measure: Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
timeFrame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Secondary outcomes:
measure: Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
timeFrame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
measure: Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
timeFrame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
measure: Responder Status
timeFrame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Ralph Hoffman
role: STUDY_CHAIR
References:
citation: 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.