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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

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

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Number of Follow-up Clinical Assessments Completed
Total Number of Treatment Emergent Adverse Events
Total Number of rTMS Sessions Completed
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,104 Total Patients Enrolled
248 Trials studying Schizophrenia
89,421 Patients Enrolled for Schizophrenia
Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,828 Total Patients Enrolled
24 Trials studying Schizophrenia
3,452 Patients Enrolled for Schizophrenia
Michael Avissar, MD, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Schizophrenia
11 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried multiple medications and it's not working. I want to get on with my life, I would like to get a job and friends. I already tried several clinical trials without success, but I am resilient. Please, let me have another chance. Thanks.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
An Extension Protocol for Patients Who Previously Completed the TMS Pilot Study
Michael Avissar 2022. "An Extension Protocol for Patients Who Previously Completed the TMS Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526833.
~1 spots leftby Apr 2025
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