Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation
概览
- 阶段
- 不适用
- 干预措施
- TMS (MagVenture MagPro 100 with MagOption)
- 疾病 / 适应症
- Healthy Volunteers
- 发起方
- National Institute on Drug Abuse (NIDA)
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
- 状态
- 招募中
- 最后更新
- 12天前
概览
简要总结
Background:
Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.
Objectives:
To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.
Eligibility:
Healthy, right-handed adults ages 18-60 who are non-drug users.
Design:
Participants will be screened under protocol 06-DA-N415.
Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.
Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.
Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.
The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.
Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.
...
详细描述
Objectives: The goal of the protocol is to investigate acute modulations of brain activity by transcranial magnetic stimulation (TMS). Using simultaneous TMS and functional magnetic resonance imaging (fMRI), we will evaluate TMS induced changes in brain activity, including regional brain activation and inter-regional functional connectivity. Repetitive TMS will be applied over the dorsolateral prefrontal cortex (DLPFC) with different frequencies and interleaved with fMRI acquisition to provide online monitoring of brain activity. Furthermore, we will assess the relationship between the TMS induced brain activity and the anatomical connection obtained from diffusion tensor imaging (DTI), using individual variations in these imaging measures. Results from this study will help to understand the underling mechanism of TMS and will provide insights for interpretation of TMS and fMRI data. Study population: Up to 70 healthy, adults will be tested. Subjects must fit exclusion/inclusion criteria for both TMS and MRI. We expect to enroll 70 subjects to arrive at 50 who complete the protocol. Design: The study is a within-subject design with each subject completing up to 6 TMS-fMRI sessions in three days (2 sessions per day) Outcome measures: The outcome measures will be the effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
研究者
入排标准
入选标准
- •INCLUSION CRITERIA:
- •Subjects must:
- •Be 18 - 60 years of age.
- •Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.
- •-Screening tool: History.
- •Be in good health.
- •Justification: Many illnesses may alter neural functioning as well as fMRI signals.
- •Screening tools: Medical Assessment, Medical History and Physical Examination. Medical assessments include: Vital Signs, oral HIV test, height/weight measurements, and blood sample. Tests on the blood sample include CBC, Hemoglobin A1C, complete metabolic profile, ESR, and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Hemoglobin \< 10.5 g/dl, Hemoglobin A1C \>6.5%, WBC \< 2400/microliter, LFTs \> 3Xnormal, and Casual serum glucose \> 200 mg/dl. The MAI will retain discretion to exclude at less extreme values, depending on the clinical presentation. Elevated serum glucose may be followed up to assess for diabetes. MAI will make the final judgment on any questionable lab results.
- •Right-handed.
- •Justification: Using right-handed individuals will reduce variability in BOLD MRI data.
排除标准
- •Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days.
- •Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Neurological symptoms could potentially alter BOLD signal.
- •Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.
- •First-degree family history of any form of epilepsy with a potentially hereditary basis.
- •Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.
- •Screening tool: TMS safety screening, Medical History.
- •Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, -shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes either MRI scanning or TMS intervention.
- •Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.
- •Screening tool: TMS safety screening, MRI safety screening, Medical History.
- •Any contraindications to MRI or TMS.
研究组 & 干预措施
TMS
All participants will receive TMS to investigate acute modulations of brain activity by TMS
干预措施: TMS (MagVenture MagPro 100 with MagOption)
结局指标
主要结局
effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.
时间窗: TMS visits
fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI