Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations Results

Yale University

Status: Terminated

Conditions: Schizophrenia

Treatments: Device: Magstim Rapid 2 system triggering Magstim Super Rapid system

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04548622

2R01MH067073 (U.S. NIH Grant/Contract)

0409027023_b

R01MH073673-02 (U.S. NIH Grant/Contract)

NARSAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Non-randomized bilateral rTMS

Experimental group

Description:

Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus

Treatment:

Device: Magstim Rapid 2 system triggering Magstim Super Rapid system