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Schizophrenia | Bilateral Repetitive Transcranial Magnetic Stimulation for Auditory Hallucinations

Schizophrenia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Schizophrenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Magstim Rapid 2 system triggering Magstim Super Rapid systemWeek 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.

Device:Magstim Rapid-2 system triggering Magstim Super Rapid systemWeek 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus

2Active rTMS to left/right Wernicke's region plus sham rTMS to opposite hemisphere middle temporal cortex

Non-randomized bilateral rTMSActive bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus

Study Status

Unknown status

Start Date: October 2007

Completed Date: October 2017

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Hallucination change score

Secondary Outcome: Summed scores of Auditory Hallucination Rating Scale

Study sponsors, principal investigator, and references

Principal Investigator: Ralph Hoffman, MD

Lead Sponsor: Yale University

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT00567281

Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104.

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