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Brain Stimulation
Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations
N/A
Waitlist Available
Led By Michael Avissar, MD, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a treatment that uses magnetic pulses to change brain activity on patients with schizophrenia who hear voices and don't respond well to other treatments. The goal is to see if this method can reduce these hallucinations by adjusting brain activity in specific areas. This non-invasive treatment has been studied for many years as a potential solution for auditory hallucinations in schizophrenia, showing promising but variable results.
Eligible Conditions
- Schizophrenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total Number of Treatment Emergent Adverse Events
Total Number of rTMS Sessions Completed
Secondary study objectives
Change in Auditory Hallucination Rating Scale (AHRS)
Change in Cardiff Anomalous Perceptions Scale (CAPS)
Change in Positive and Negative Syndrome Scale (PANSS)- General Psychopathology
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Individualized magnetic resonance imaging (MRI) guided rTMSExperimental Treatment1 Intervention
Participants will receive a type of TMS called repetitive TMS (rTMS) wherein the magnetic pulses delivered will be close together in a rapid sequence. They will receive a 20-min once-daily rTMS sessions over a period of 2 weeks (weekends off), and therefore accrue a total of 10 rTMS stimulation sessions. The rTMS parameters that will be used are a frequency of 1 Hz (1 pulse per second) at an intensity of 90% of the motor threshold (MT). Therefore, the investigators will deliver 1200 continuous pulses per session/day which adds up to 12,000 pulses in total for the whole treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,630 Total Patients Enrolled
256 Trials studying Schizophrenia
90,414 Patients Enrolled for Schizophrenia
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,768,970 Total Patients Enrolled
24 Trials studying Schizophrenia
3,315 Patients Enrolled for Schizophrenia
Michael Avissar, MD, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Schizophrenia
3 Patients Enrolled for Schizophrenia