Repetitive Transcranial Magnetic Stimulation for "Voices"

Phase 2

Completed

Interventions: Device: repetitive transcranial magnetic stimulation (rTMS)
Device: sham stimulation

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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
active rTMS	repetitive transcranial magnetic stimulation (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)
sham stimulation	sham stimulation	Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Primary Outcome Measures

Name	Time	Method
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)	Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)	Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)	Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened
Responder Status	After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)	Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions. Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline