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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 belowExclusion 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
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.
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.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
936 Previous Clinical Trials
335,881 Total Patients Enrolled
6 Trials studying Schizophrenia
415 Patients Enrolled for Schizophrenia
University of Maryland, BaltimoreLead Sponsor
710 Previous Clinical Trials
379,109 Total Patients Enrolled
67 Trials studying Schizophrenia
10,194 Patients Enrolled for Schizophrenia
Xiaoming Du, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
320 Total Patients Enrolled
3 Trials studying Schizophrenia
320 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 22 and 65 years old.I have a condition that increases my risk of seizures.I have had a head injury with unconsciousness for over 10 minutes or brain surgery.I am currently seeing a doctor or mental health professional.I have a close family member with inherited epilepsy or seizures.I have tried to quit smoking in the last four weeks.I have a cardiac pacemaker, medication pump, intracardiac lines, or unstable heart condition.I take more than 400 mg of clozapine daily or I did not pass the TMS screening.I am not pregnant and have used birth control consistently for the last 4 weeks.I do not have any major illnesses that affect my brain's functioning.I am between 18 and 60 years old.You have smoked within the past year and have been smoking an average of 5 or more cigarettes per day in the past 4 weeks.You have smoked cigarettes regularly within the past year, and you smoke at least 5 cigarettes a day in the last 4 weeks.You are diagnosed with schizophrenia-spectrum disorder and you are over the age of 18.
Research Study Groups:
This trial has the following groups:- Group 1: Study group
- Group 2: Active control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05276050 — N/A
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