NCT06639594招募中1 期
Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs).
研究概览
简要总结
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
详细描述
Primary Objectives:
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
- Recruitment: We will define recruitment as the probability of an eligible patient consenting to participate in the study. We will deem recruitment for this trial feasible if at least 70% of eligible patients consent to participate in the trial. (i.e., considering a pool of 30 eligible subjects, we consent at least 21 participants).
- Tolerability: For each sequence, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS sequence.
- Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.
Secondary Objectives
We will measure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 to 60
- •BMI>30 (confirmed at in person visit)
- •Able to follow verbal and written instructions in English and complete all aspects of the study.
- •Have an address and telephone number where they may be reached.
- •Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
- •Meet safety criteria for EEG and rTMS.
- •Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
- •Provides written informed consent and agree to all assessments and study procedures.
- •Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.
排除标准
- •rTMS exposure for treatment or research purposes in the last 6 months.
- •History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- •Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
- •History of brain surgery, implanted electronic device, metal in the head.
- •Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
- •History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
- •Reported history of vision problems that are not treated.
- •Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
- •Reports current diagnosis or history of type I diabetes.
- •Currently using insulin.
- •Have undergone bariatric surgery.
- •Currently being enrolled in a weight loss program
- •Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
- •Self-report a history of or current diagnosis of a mental health condition.
- •Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
- •Reports (<4 hours of sleep) the day of the visit.
- •Reports using marijuana on a daily basis.
- •Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
- •Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
- •Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.
- •Current use of certain medications (last 3 months):
- •Investigational drugs.
- •Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
- •Medications known to increase risk of seizure taken within 1 week of enrollment.
- •Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
- •Being pregnant or lactating
- •Reported allergies to chocolate or any ingredient in the M&M candies.
- •Noise-induced hearing loss or tinnitus.
- •Currently participating in any other research study.
- •Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician
- •Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
研究组 & 干预措施
Intermittent theta burst stimulation
Experimental
Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive intermittent theta burst stimulation (iTBS)" for 3 sessions; in week 2 participants receive continuous theta burst stimulation ciTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Continuous theta burst stimulation
Experimental
Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Safety and Adverse Events (AEs).
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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