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1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation for Schizophrenia (rTMS-EM Trial)

N/A
Waitlist Available
Led By Tom Hummer
Research Sponsored by Indiana 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 1 day
Awards & highlights

rTMS-EM Trial Summary

This trial will test the effects of two types of magnetic stimulation on people with a history of clinically significant psychotic symptoms. The first type, inhibitory (1 Hz) rTMS, will be delivered to the precuneus on one occasion. The second type, excitatory (20 Hz) rTMS, will be delivered on a different occasion, with the order of the two types of stimulation being randomized. Each subject will also undergo a sham stimulation session. The investigators will also examine the effect of rTMS on performance on a task involving emotional processing.

rTMS-EM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Precuneus Functional Activation
Performance During In-scanner Episodic Memory Task
Precuneus Functional Connectivity

rTMS-EM Trial Design

6Treatment groups
Experimental Treatment
Group I: sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS StimulationExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Group II: sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS StimulationExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Group III: 20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS StimulationExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Group IV: 20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMSExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Group V: 1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS StimulationExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Group VI: 1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMSExperimental Treatment2 Interventions
Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham rTMS Stimulation
2019
N/A
~30
1 Hz rTMS Stimulation
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,957 Total Patients Enrolled
14 Trials studying Schizophrenia
992 Patients Enrolled for Schizophrenia
Tom HummerPrincipal InvestigatorIndiana University
Michael Francis, MD5.02 ReviewsPrincipal Investigator - Indiana University
Medical School - Indiana University, Doctor of Medicine
Saint Francis Hospital (Residency)
3 Previous Clinical Trials
54 Total Patients Enrolled
2 Trials studying Schizophrenia
40 Patients Enrolled for Schizophrenia
5Patient Review
Dr. Teague is very friendly and helpful. He takes the time to explain things in a way that is easy to understand.

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia
Tom Hummer 2019. "rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04182113.
~5 spots leftby Apr 2025
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