Repetitive Transcranial Magnetic Stimulation for "Voices"

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00004980
• Lead Sponsor: Yale University

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

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-03-10
• Study First Submitted QC: 2000-03-10
• Study First Posted: 2000-03-13
• Primary Completion: 2005-01
• Study Completion: 2005-06
• Results First Submitted: 2008-11-25
• Results First Submitted QC: 2012-06-05
• Results First Posted: 2012-07-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States