Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Yale University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions
Time Frame: 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 Outcomes
- 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))
- 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))
- Responder Status(After the 9th active/sham rTMS session (up to 2 weeks or end of intervention))