Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results

Not Applicable

Terminated

• Conditions: Schizophrenia
• Interventions: Device: Magstim Rapid 2 system triggering Magstim Super Rapid system

• Registration Number: NCT04548622
• Lead Sponsor: Yale University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Results First Submitted: 2020-09-14
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-08
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-10-30
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Previously enrolled in our "parent" rTMS trial with passage of at least six months since last received active rTMS

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-randomized bilateral rTMS	Magstim Rapid 2 system triggering Magstim Super Rapid system	Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus

Primary Outcome Measures

Name	Time	Method
PANSS Composite Positive Symptoms Hallucination Score	baseline to 4 weeks	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.
PANSS Composite Negative Symptom Scale	baseline to 4 weeks	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.
PANSS Total Score	baseline to 4 weeks	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.

Trial Locations

Locations (1)

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