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Non-invasive Brain Stimulation
TMS for Nicotine Addiction
N/A
Recruiting
Led By Travis E Lalta, PhD
Research Sponsored by Rutgers, The State University of New Jersey
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 day 0 (day of testing)
Awards & highlights
Study Summary
This trial will measure how well various TMS targeting techniques reduce smoking cravings, increase decision-making abilities, and if TMS has a lasting effect on smokers.
Who is the study for?
This trial is for individuals aged 18-55 with nicotine addiction who are in good mental and physical health, can follow the study plan, and haven't had substance abuse treatment recently. Pregnant women or those with brain lesions, metal implants affecting MRI scans, or certain neurological conditions cannot participate.Check my eligibility
What is being tested?
The study tests whether a type of brain stimulation called 10-Hz TMS aimed at the DLPFC affects reward activity in smokers. It's a controlled experiment comparing real TMS to sham (fake) treatment over three sessions to see if it helps decision-making and reduces cravings.See study design
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. The sham procedure should have no side effects but might include similar sensations as the active TMS due to its placebo nature.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 (day of testing)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (day of testing)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-related Brain Potential: Reward Positivity
Secondary outcome measures
Approach Learning
Avoidance Learning
Nicotine Craving
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TMSExperimental Treatment1 Intervention
Participants in the active condition will receive repetitive TMS (rTMS), delivered at 110% of participants' resting motor threshold at 10 Hz continuously over the predefined prefrontal target for a total of 1000 pulses. Within each of the two TMS sessions, two targets will be stimulated.
Group II: Sham TMSPlacebo Group1 Intervention
Identical parameters will be applied to the SHAM group with the exception that the TMS coil will be flipped 180º to mimic auditory stimulation.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,196 Total Patients Enrolled
Travis E Lalta, PhDPrincipal InvestigatorRutgers University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of brain-related autoimmune, endocrine, viral, or vascular disorders.I have never been diagnosed with bipolar disorder, schizophrenia, PTSD, dementia, or major depression.I have a neurological disorder that affects my brain or physical abilities.I do not have a history of major neurological issues, metal in my head, or an implanted electronic device, and I am not pregnant.I am between 18 and 55 years old.My mental and physical health is stable.I am not pregnant.I am on constant medication for my brain or nerves.
Research Study Groups:
This trial has the following groups:- Group 1: Active TMS
- Group 2: Sham TMS
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the eligibility limit for this medical trial restricted to individuals under 25 years of age?
"Eligible participants for this medical study must be between 18 to 55 years old."
Answered by AI
Is it possible for me to partake in this research study?
"Applicants must be nicotine addicts of ages 18 to 55 in order to qualify for this clinical trial. 36 individuals will ultimately be admitted into the study."
Answered by AI
Are individuals in need of medical care able to participate in this study?
"According to the latest information found on clinicaltrials.gov, this clinical trial is currently in need of participants. The experiment was initially posted on March 1st 2023 and has since been revised as recently as March 2nd 2023."
Answered by AI
How many participants have been enlisted in this research endeavor?
"Affirmative. Clinicaltrials.gov attests that this research is actively seeking participations, having originally been posted on March 1st 2023 and updated more recently on the 2nd of the same month. The study requires 36 individuals to be recruited at a single site."
Answered by AI
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