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Search / Trial NCT03544333

Boost rTMS for Auditory Verbal Hallucinations

Launched by NORTHWELL HEALTH · May 21, 2018

Trial Information

Current as of May 16, 2025

Terminated

Keywords

Transcranial Magnetic Stimulation (Tms) Brain Stimulation Medication Free

ClinConnect Summary

Auditory verbal hallucinations affect up to 70% of schizophrenia patients (Waters, 2012), yet, even extended antipsychotic medication does not ameliorate AVH in 20-30% of patients (Sukhwinder S Shergill et al., 2007) and is often accompanied by side effects (Leucht et al., 2009). Therefore, it is crucial to develop and assess promising potentially beneficial therapeutic options.

Non-invasive brain stimulation techniques like repetitive transcranial magnetic stimulation (rTMS) have been proposed to disrupt mechanisms in question. A number of meta-analyses (Aleman, Sommer, \& Kahn, 2007; Dem...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Provision of signed and dated informed consent form
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3. Male or female, aged 18 to 65
  • 4. 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
  • 5. Willing to adhere to the rTMS regimen
  • 6. 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
  • 7. Agreement to adhere to Lifestyle Considerations throughout study duration
  • Exclusion Criteria:
  • 1. Current use of antipsychotic medication within the last 2 weeks
  • 2. Electroconvulsive therapy or rTMS within three months (see the TMS screening questionnaire)
  • 3. History of seizures
  • 4. Presence of implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc.)
  • 5. Pregnancy, as assessed with a pregnancy test prior to every MRI measurement, or lactation
  • 6. Any active general medical condition or central nervous system disease which can affect cognition or response to treatment
  • 7. Treatment with another investigational drug or other intervention within 2 weeks
  • 8. 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.
  • 9. Patients who are cognitively impaired and are thus not able to give informed consent

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Manhasset, New York, United States

Patients applied

0 patients applied

Trial Officials

Philipp Homan, MD PhD

Principal Investigator

Zucker Hillside Hospital, New York City, USA.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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