New Haven, Connecticut 06519


Purpose:

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.


Study summary:

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 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. We have added a third arm to the protocol (3/2012) where the same intervention described for Arm 1 is provided to enrollees, but no randomization or comparison with Arm 2 is pursued. The primary purpose of this Arm is to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. Our intent is 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. This combined fMRI/rTMS study will provide critical new insights into the neurobiological basis of auditory hallucinations.


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


NCT ID:

NCT00567281


Primary Contact:

Principal Investigator
Ralph Hoffman, MD
Yale University

Ralph E Hoffman, MD
Phone: 203-688-9734
Email: ralph.hoffman@yale.edu


Backup Contact:

Email: ralph.hoffman@yale.edu
Ralph Hoffman, MD
Phone: 203-688-9734


Location Contact:

New Haven, Connecticut 06519
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 16, 2017

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