- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06639594
충동 조절 장애에 대한 보조제로서 가속화된 맞춤형 rTMS의 타당성: 파일럿 연구 (RAPID)
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
연구 개요
상세 설명
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:
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To measure the time required to the staff to conduct each ERP assessment.
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To measure the time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
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We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Francesco Versace, PHD, PHD
- 전화번호: (713) 745-7933
- 이메일: fversace@mdanderson.org
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- 모병
- The University of Texas MD Anderson Cancer Center
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연락하다:
- Francesco Versace, PHD,PHD
- 전화번호: 713-745-7933
- 이메일: fversace@mdanderson.org
-
수석 연구원:
- Francesco Versace, PHD,PHD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria
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rTMS exposure for treatment or research purposes in the last 6 months.
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History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
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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).
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History of brain surgery, implanted electronic device, metal in the head.
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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)
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History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
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Reported history of vision problems that are not treated.
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Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
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Reports current diagnosis or history of type I diabetes.
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Currently using insulin.
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Have undergone bariatric surgery.
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Currently being enrolled in a weight loss program
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Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
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Self-report a history of or current diagnosis of a mental health condition.
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Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
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Reports (<4 hours of sleep) the day of the visit.
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Reports using marijuana on a daily basis.
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Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
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Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
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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.
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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).
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Being pregnant or lactating
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Reported allergies to chocolate or any ingredient in the M&M candies.
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Noise-induced hearing loss or tinnitus.
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Currently participating in any other research study.
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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
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Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intermittent theta burst stimulation
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. |
RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil. |
|
실험적: Continuous theta burst stimulation
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. |
RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and Adverse Events (AEs).
기간: Through study completion; an average of 1 year.
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Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Through study completion; an average of 1 year.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Francesco Versace, PHD,PHD, The Unversity of Texas MD Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-0261
- NCI-2024-08561 (기타 식별자: NCI CTRP Clinical Registry)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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