Repetitive Transcranial Magnetic Stimulation for "Voices"

Yale University

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Device: sham stimulation; Device: repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004980

R21MH063326 (U.S. NIH Grant/Contract)

A5-ETPD

199/14809

YALESM-9281

Details and patient eligibility

About

OBJECTIVES:

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

active rTMS

Experimental group

Description:

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)

Treatment:

Device: repetitive transcranial magnetic stimulation (rTMS)

sham stimulation

Placebo Comparator group

Description:

Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Treatment:

Device: sham stimulation