OBJECTIVES: I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site
132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site
Yale University School of Medicine
New Haven, Connecticut, United States
Hallucination Change Score (HCS) After 9 Active/Sham 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
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions
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.
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions
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
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
Responder Status
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
Time frame: After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)
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