Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results

Study Overview
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Brief Summary
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The primary purpose of this study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by the primary outcome variables.

Detailed Description
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This study is an extension of previous clinical trials (NCT00308997 and NCT00567281) that were initiated in 2006. This study record provides the results for the amended study NCT00567281 (originally called a 'third arm') that was discontinued following the passing of Dr. Ralph Hoffman. The primary purpose of the study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by our primary outcome variables. It was hoped that this combined fMRI/rTMS study would provide critical new insights into the neurobiological basis of auditory hallucinations. The results presented are what was summarized following Dr. Hoffman's passing and were compiled by Dr. Philip Corlett.

Official Title
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Bilateral rTMS Clinical Trial for Persistent Auditory Hallucinations Results for a Terminated Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Magstim Rapid 2 system triggering Magstim Super Rapid system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously enrolled in our parent rTMS trial with passage of at least six months since last received active rTMS Exclusion Criteria: Active substance abuse or alcohol abuse Pregnancy Dose or type of psychiatric medication changed within the 4 weeks prior to study entry Recent head trauma, seizures, or significant unstable medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-randomized bilateral rTMS<br>Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus | Device: Magstim Rapid 2 system triggering Magstim Super Rapid system<br>* Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS Composite Positive Symptoms Hallucination Score | The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS positive symptoms hallucinication score has a range of 1-7. Higher scores indicate more severe positive symptoms in patients with schizophrenia. | baseline to 4 weeks | 
| PANSS Composite Negative Symptom Scale | The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS negative scale has 7 Items, with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe negative symptoms in patients with schizophrenia. | baseline to 4 weeks | 
| PANSS Total Score | The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS total score has a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms in patients with schizophrenia. | baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizoaffective disorder, Auditory Hallucinations, Voices, Repetitive Transcranial Magnetic Stimulation, rTMS, Wernicke's Area, Middle Temporal Cortex, Persistent Auditory Hallucinations, Previously Participated in Parent rTMS Protocol