Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04548622|
Recruitment Status : Terminated (Dr. Ralph Hoffman unexpectedly passed away.)
First Posted : September 14, 2020
Results First Posted : October 30, 2020
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Device: Magstim Rapid 2 system triggering Magstim Super Rapid system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- PANSS Composite Positive Symptoms Hallucination Score [ 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 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 [ 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.
- PANSS Total Score [ 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 total score has a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms in patients with schizophrenia.
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
|United States, Connecticut|
|Department of Psychiatry, Yale School of Medicine|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Philip Corlett, PhD||Yale University Department of Psychiatry|