Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Original Study

Not Applicable

Completed

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

• Registration Number: NCT00567281
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

This study record has been amended to remove a third arm that was added in 2012. The third arm described was not actually a comparative arm, but rather an added objective with a different study population. Dr. Ralph Hoffman unexpectedly passed away while this study was being conducted. This study has been submitted as a separate study (NCT04548622) where the summarized study results of the terminated study will be presented.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Magstim Rapid 2 system triggering Magstim Super Rapid system	Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus
2	Magstim Rapid-2 system triggering Magstim Super Rapid system	Active rTMS to left/right Wernicke's region plus sham rTMS to opposite hemisphere middle temporal cortex

Primary Outcome Measures

Name	Time	Method
Hallucination change score	Measured at every week over a total 4 weeks
Clinical Global Improvement Scale	Measured at every week over a total of 4 weeks
Frequency subscale of Auditory Hallucinations Rating Scale	Measured at baseline and every week over a total of 4 weeks

Secondary Outcome Measures

Name	Time	Method
Summed scores of Auditory Hallucination Rating Scale	Measured at baseline and every week over a total of 4 weeks
PANSS total score	Measured at baseline and every week over a total of 4 weeks
PANSS composite positive symptoms scale	Measured at baseline and every week over a total of 4 weeks
PANSS composite negative symptom scale	Measured at baseline and every week over a total of 4 weeks
California Verbal Learning Test (CVLT)	Measured at baseline and every week over a total of 4 weeks

Trial Locations

Locations (1)

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