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Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results

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ClinicalTrials.gov Identifier: NCT04548622
Recruitment Status : Terminated (Dr. Ralph Hoffman unexpectedly passed away.)
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Magstim Rapid 2 system triggering Magstim Super Rapid system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bilateral rTMS Clinical Trial for Persistent Auditory Hallucinations Results for a Terminated Study
Study Start Date : September 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Non-randomized bilateral rTMS
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
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.




Primary Outcome Measures :
  1. PANSS composite positive symptoms scale [ Time Frame: 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 scale has 7 Items, with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe positive symptoms in patients with schizophrenia.

  2. PANSS composite negative symptom scale [ Time Frame: 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.

  3. PANSS total score [ Time Frame: baseline to 4 weeks ]
    he 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548622


Locations
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United States, Connecticut
Department of Psychiatry, Yale School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Philip Corlett, PhD Yale University Department of Psychiatry
Additional Information:
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04548622    
Other Study ID Numbers: 0409027023_b
R01MH073673-02 ( U.S. NIH Grant/Contract )
NARSAD
2R01MH067073 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Keywords provided by Yale University:
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
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases