Repetitive Transcranial Magnetic Stimulation (rTMS) for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York State Psychiatric Institute, New York, NYSchizophreniaRepetitive Transcranial Magnetic Stimulation (rTMS) - Device
Eligibility
22 - 55
All Sexes
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Up to 4/8 weeks.

2 weeks
Change in Clinical Global Impression Improvement (CGI-I) Scale
Change in Clinical Global Impression Severity (CGI-S) Scale
2 weeks.
Total number of rTMS sessions completed
Total number of treatment emergent adverse events
8 weeks
Total number of follow-up clinical assessments completed
Up to 4/8 weeks.
Change in Auditory Hallucination Rating Scale (AHRS)
Change in Cardiff Anomalous Perceptions Scale (CAPS)
Change in Positive and Negative Syndrome Scale (PANSS)
Change in Psychotic Symptom Rating Scale (PSYRATS)
Change in Scale for the Assessment of Positive Symptoms (SAPS)

Trial Safety

Trial Design

3 Treatment Groups

Complete responders undergo four follow-up clinical assessments
1 of 3
Partial responders undergo rTMS of the left temporo-parietal junction (TPJ)
1 of 3
Non-responders undergo rTMS of the right superior temporal sulcus (STS)
1 of 3

Active Control

Experimental Treatment

12 Total Participants · 3 Treatment Groups

Primary Treatment: Repetitive Transcranial Magnetic Stimulation (rTMS) · No Placebo Group · N/A

Partial responders undergo rTMS of the left temporo-parietal junction (TPJ)
Device
Experimental Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) · Intervention Types: Device
Non-responders undergo rTMS of the right superior temporal sulcus (STS)
Device
Experimental Group · 1 Intervention: Repetitive Transcranial Magnetic Stimulation (rTMS) · Intervention Types: Device
Complete responders undergo four follow-up clinical assessmentsNoIntervention Group · 1 Intervention: Complete responders undergo four follow-up clinical assessments · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2011
Completed Phase 2
~710

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4/8 weeks.

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,312 Previous Clinical Trials
1,623,954 Total Patients Enrolled
21 Trials studying Schizophrenia
1,945 Patients Enrolled for Schizophrenia
Michael Avissar, MD, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Schizophrenia
12 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 22 - 55 · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with schizophrenia or schizoaffective disorder according to the DSM-5.
You are right-handed.
You have been diagnosed with schizophrenia or schizoaffective disorder as per DSM-5 guidelines.
You have good hearing.

Frequently Asked Questions

Is the trial still open for enrollment?

"Correct. As of the most recent update on September 15, 2022, this clinical trial is still open and actively recruiting participants. This research project was initially posted online with a start date of September 12th 2022." - Anonymous Online Contributor

Unverified Answer

What is the participant recruitment rate for this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this medical trial, first posted on 12th September 2022 is seeking enrolment from 12 individuals at a single location. The study was last updated on the 15th of September that same year." - Anonymous Online Contributor

Unverified Answer

What is the goal of this experiment?

"This medical trial will have an 8-week assessment period, during which the primary outcome of interest is the total number of adverse events that occur. Additionally, changes in Clinical Global Impression Improvement (CGI-I) Scale, Psychotic Symptom Rating Scale (PSYRATS), and Clinical Global Impression Severity (CGI-S) Scale scores are also examined as secondary outcomes. These scales measure overall illness improvement or severity on a 7 point scale ranging from 1 to 7 respectively." - Anonymous Online Contributor

Unverified Answer

Is this research project accessible to those under the age of fifty?

"As stated in the criteria for participation, this clinical trial has a lower age limit of 22 and an upper age limit of 55." - Anonymous Online Contributor

Unverified Answer

Can I qualify for the experiment?

"This research project is recruiting twelve individuals between 22 and 55 years of age with behavioral disorders. To be accepted, they must fulfill the following requirements: having completed study #8116 (NCT05319080), DSM-V diagnosis of schizophrenia or schizoaffective disorder, a Reduction in AHRS lower than 50% at baseline, capacity to provide informed consent for participation and willingness to comply with contraception protocols if female and not infertile; have negative pregnancy test results if applicable; right handedness; normal hearing levels; taking an antipsychotic medication at stable dose for 4 weeks minimum. All oral and depot drugs are permitted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.