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Active 10 Hz rTMS for Schizophrenia (ModSoCCS Trial)

N/A

Waitlist Available

Led By Aristotle Voineskos, MD

Research Sponsored by Centre for Addiction and Mental Health

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 2 weeks

Awards & highlights

ModSoCCS Trial Summary

This trial will test the effects of two types of brain stimulation on social cognition in people with schizophrenia spectrum disorders.

Eligible Conditions

Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

ModSoCCS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Change in mentalizing brain network functional connectivity

Secondary outcome measures

Treatment Tolerability

ModSoCCS Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active 10 Hz rTMSActive Control1 Intervention

Active treatment will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered at 10 Hz according to conventional FDA-approved parameters (4 s on and 26 s off; 3000 pulses per session; total duration 37.5 mins) .

Group II: Active iTBSActive Control1 Intervention

Active iTBS will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered in triplet 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 9 seconds.

Group III: Sham rTMSPlacebo Group1 Intervention

Sham stimulation will be delivered using the same stimulation parameters as either 10 Hz rTMS or iTBS. For both active and sham stimulation, TMS coil positioning for each individual will be optimized by combining participant fMRI data, meta-analytic functional analysis, electric field modelling, and real-time neuronavigation.

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Find a Location

Who is running the clinical trial?

University of Maryland School of MedicineUNKNOWN

4 Previous Clinical Trials

716 Total Patients Enrolled

University of Maryland, BaltimoreOTHER

687 Previous Clinical Trials

374,576 Total Patients Enrolled

66 Trials studying Schizophrenia

10,187 Patients Enrolled for Schizophrenia

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,518 Total Patients Enrolled

10 Trials studying Schizophrenia

1,404 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.

What qualifications must someone possess in order to be eligible for this medical experiment?

"This clinical trial is inviting 60 individuals, aged between 18 and 55 years old with a diagnosis of schizophrenia to take part in the study. The necessary criteria for eligibility also include: age range of 18-55; male or female gender identity."

Answered by AI

How many participants are being accepted into this clinical trial?

"Affirmative. The details provided on clinicaltrials.gov signify that this experiment, which was originally posted on November 30th 2020, is actively enrolling individuals into the program. Approximately 60 participants must be found from 3 distinct sites."

Answered by AI

Is admission to this research project open at the moment?

"That is correct. Per the information on clinicaltrials.gov, this trial was initially posted on November 30th 2020 and actively recruiting as of April 16th 2021. Sixty individuals need to be recruited from 3 distinct sites for the study's completion."

Answered by AI

Does the age restriction for this clinical experiment lie at 35 years or below?

"This research is limited to participants aged 18-55. However, there are 321 studies designed for individuals younger than 18 and 783 trials available for those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders

2020. "Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04418011.