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Repetitive Transcranial Magnetic Stimulation (rTMS) for Schizophrenia

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 up to 4/8 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is an extension of a previous study investigating the efficacy of transcranial magnetic stimulation (TMS) on patients with schizophrenia. The extension study will further assess the safety and efficacy of TMS on these patients. Patients who have completed the 4-week project #8116 can be screened for eligibility for this extension study in which they will continue treatment/assessment.

Eligible Conditions

Schizophrenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4/8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4/8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4/8 weeks. for reporting.

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 Follow-up Clinical Assessments Completed

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 Clinical Global Impression Improvement (CGI-I) Scale

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Partial responders undergo rTMS of the left temporo-parietal junction (TPJ)Experimental Treatment1 Intervention

Partial responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the original left temporo-parietal junction (TPJ) target. 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.

Group II: Non-responders undergo rTMS of the right superior temporal sulcus (STS)Experimental Treatment1 Intervention

Non-responders to protocol #8116 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 be administered 10 days (10 sessions) of MRI-guided 1 Hz rTMS delivered to the right superior temporal sulcus (STS). 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.

Group III: Complete responders undergo four follow-up clinical assessmentsActive Control1 Intervention

Complete responders to protocol #8116 will be offered followup clinical assessments at 1, 2, 4, and 8 weeks to assess sustainability of their response.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

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