Boost rTMS for Auditory Verbal Hallucinations

Stopped early · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Auditory Hallucination

In brief

This is a randomized, placebo controlled, double-blind clinical trial. The investigators aim to examine the safety and efficacy of repeated transcranial magnetic stimulation (rTMS) for the treatment of auditory verbal hallucinations (AVH) in patients with schizophrenia who are not taking antipsychotic medication. The investigators employ a novel, accelerated protocol with only four sessions of low-frequency rTMS in one day. The effects of this accelerated protocol will be compared to the sham stimulation. Additionally, the investigators will examine the effects of rTMS on a neurophysiological level by evaluating mechanism of action in the temporo-parietal lobe by means of functional magnetic resonance imaging.

Key facts

Study ID

NCT03544333

Run by

Northwell Health

People needed

5

Starts

2018-04-16

Expected to finish

2019-01-22

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 to 65
• Diagnosed with Diagnostic and Statistical Manual (DSM) V diagnosis of schizophrenia (295.90), schizoaffective disorder (295.70), or brief psychotic disorder (298.80), prone to AVH in the acute phases of the disorder
• Willing to adhere to the rTMS regimen
• No antipsychotic medication in the last two weeks prior to the start of the study as well as no antipsychotic medication during participation in the study
• Agreement to adhere to Lifestyle Considerations throughout study duration

You may not qualify if…

• Current use of antipsychotic medication within the last 2 weeks
• Electroconvulsive therapy or rTMS within three months (see the TMS screening questionnaire)
• History of seizures
• Presence of implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc.)
• Pregnancy, as assessed with a pregnancy test prior to every MRI measurement, or lactation
• Any active general medical condition or central nervous system disease which can affect cognition or response to treatment
• Treatment with another investigational drug or other intervention within 2 weeks
• Current diagnosis of delirium, dementia, or amnestic amnesiac disorder; Diagnosis of mental retardation; Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
• Patients who are cognitively impaired and are thus not able to give informed consent

Where it is running

• The Zucker Hillside Hospital, Northwell Health — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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