What side effects are associated with this type of intervention?

Repetitive transcranial magnetic stimulation (rTMS) for schizophrenia is generally well-tolerated, with common side effects including mild headaches, scalp discomfort at the stimulation site, and lightheadedness. Serious adverse events are rare. Other common treatments for schizophrenia, such as antipsychotic medications, can have side effects like weight gain, drowsiness, dry mouth, and in some cases, more severe effects like tardive dyskinesia (involuntary movements) and metabolic syndrome.

What prior FDA approvals exist?

The FDA has approved various treatments for schizophrenia, primarily focusing on antipsychotic medications. However, repetitive transcranial magnetic stimulation (rTMS) is an emerging neuromodulation technique being studied for its potential benefits in treating schizophrenia. While rTMS is not yet FDA-approved specifically for schizophrenia, it has shown promise in clinical trials for other psychiatric conditions, such as major depressive disorder. The ongoing research aims to establish its efficacy and safety for schizophrenia, potentially offering a non-invasive alternative to traditional pharmacotherapy.

What other types of research exist?

Promising novel alternatives to rTMS for schizophrenia patients include transcranial direct current stimulation (tDCS) and external trigeminal neurostimulation (eTNS). These methods have shown potential in modulating brain activity and alleviating symptoms in various neurological and psychiatric conditions.

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Behavioural Intervention

TMS for Smoking Cessation in Schizophrenia

Verified Trial

N/A

Recruiting

Led By Xiaoming Du, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You have been diagnosed with Schizophrenia

22-65 years-old

Must not have

Lives 30+ miles from UTHealth Houston

Taking > 400 mg clozapine/day or Failed TMS screening questionnaire

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a magnetic pulse device to help people with schizophrenia stop smoking. It targets specific brain areas involved in both conditions. The goal is to see if this method is effective for this particular group. This method has been shown to decrease cigarette consumption in schizophrenia patients.

Who is the study for?

This trial is for adults aged 18-60 who smoke at least 5 cigarettes daily for the past year, have schizophrenia spectrum disorder, and can consent to participate. Excluded are those with certain metal implants, severe head injuries, pregnancy or unprotected sex without birth control recently, active suicidal thoughts or behaviors, recent substance abuse (except nicotine/marijuana), specific medication dosages or medical conditions affecting brain function.

What is being tested?

The study tests two types of rTMS treatments using F8-coil and H-coil on patients with schizophrenia for smoking cessation. It measures changes in smoking behavior and brain connectivity before treatment, during different stages of rTMS therapy, and at follow-up sessions.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I take more than 400 mg of clozapine daily or I did not pass the TMS screening.

Select...

I have a condition that increases my risk of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cigarette per day

Resting-state functional connectivity (rsFC) from functional magnetic resonance imaging (fMRI)

Secondary study objectives

End-expired carbon monoxide (CO)

Fagerstrom Test for Nicotine Dependence (FTND)

nicotine/creatinine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study groupExperimental Treatment1 Intervention

Participants in this group will receive active F8-coil delivered rTMS.

Group II: Active control groupActive Control1 Intervention

Participants in this group will receive active H-coil delivered rTMS.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Schizophrenia treatments primarily aim to modulate brain activity to alleviate symptoms. Antipsychotic medications, the most common treatment, work by blocking dopamine receptors, which helps reduce psychotic symptoms like hallucinations and delusions. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuromodulation technique that uses magnetic fields to stimulate specific brain regions, potentially improving symptoms by altering neural activity and connectivity. This is particularly important for schizophrenia patients as it offers an alternative for those who do not respond well to medications, providing a non-pharmacological option to manage their condition.