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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00567281 |
This trial is designed to determine if administering repetitive transcranial magnetic stimulation (rTMS) simultaneously to two sites in the temporal lobes, one on the left and one on the right, produces greater improvements in "voices" and other symptoms of schizophrenia compared to rTMS given to just one site in the temporal lobes.
Condition | Intervention | Phase |
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Schizophrenia |
Device: Magstim Rapid 2 system triggering Magstim Super Rapid system Device: Magstim Rapid-2 system triggering Magstim Super Rapid system |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Re-Enrollment Bilateral rTMS Clinical Trial for Persistent Auditory Hallucinations |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus
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Device: Magstim Rapid 2 system triggering Magstim Super Rapid system
Week 1 treatment includes rTMS for 5 sessions to either to left or 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.
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2: Active Comparator
Active rTMS to left/right Wernicke's region plus sham rTMS to opposite hemisphere middle temporal cortex
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Device: Magstim Rapid-2 system triggering Magstim Super Rapid system
Week 1 includes repetitive rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with sham rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 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, sham 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.
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This study is an extension of an ongoing clinical trial (ClinicalTrials.gov identifier NCT 00308997) that was initiated in 2006. The primary objective of the ongoing clinical trial (hereafter called the "parent trial") is to determine efficacy of rTMS in curbing auditory hallucinations when delivered to a part of the left temporal lobe called Wernicke's area and a corresponding region in the right temporal lobe. The parent trial appears to show robust effects for active rTMS compared to effects of sham stimulation. However, observed responses following active rTMS have often been incomplete. Moreover, in some cases there has been a subsequent return of symptoms 1 to 6 months after the trial ended.
We consequently have initiated a re-enrollment trial where patients who have participated in the parent trial and demonstrated an incomplete response or a subsequent return of symptoms may return to receive additional active rTMS. We hypothesize that efficacy of suppressive rTMS will be enhanced if directed simultaneously to right/left Wernicke's area (the site used in the parent trial) as well as to a second site located in the opposite middle temporal cortex. Roughly half of subjects in the re-enrollment will be randomized to receive active rTMS to right/left Wernicke's area plus active rTMS to opposite hemisphere middle temporal region, while half of subjects will be randomized to receive active rTMS to right/left Wernicke's area plus sham rTMS to opposite hemisphere middle temporal region. The position of the middle temporal regions will be determined by two recently completed brain imaging studies of auditory hallucinations suggesting that activation in these sites triggers auditory hallucinations. The two-position design will allow us to determine if active rTMS delivered to the middle temporal cortex is superior in amplifying efficacy of active rTMS targeting Wernicke's area and in reducing auditory hallucinations to sham stimulation to the same site. The re-enrollment protocol will utilize two rTMS devices simultaneously where one directly triggers the other.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Department of Psychiatry, Yale School of Medicine | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Ralph Hoffman, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Ralph Hoffman MD ) |
Study ID Numbers: | R01 MH073673-02, R01 MH73673, NARSAD |
Study First Received: | December 3, 2007 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00567281 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Schizophrenia Signs and Symptoms Mental Disorders Hallucinations Neurologic Manifestations |
Psychotic Disorders Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Perceptual Disorders |
Schizophrenia Signs and Symptoms Mental Disorders Nervous System Diseases Hallucinations |
Neurologic Manifestations Neurobehavioral Manifestations Schizophrenia and Disorders with Psychotic Features Perceptual Disorders |