Functional Connectivity as a Biomarker of rTMS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Functional Connectivity (FC) Changes Between the Left Hippocampus and Left Parietal Cortex
研究概览
简要总结
Background:
Traumatic brain injury (TBI) damages the connections between brain cells. This can lead to problems like memory loss. Repetitive transcranial magnetic stimulation (rTMS) can help improve connections between brain areas in healthy people. Researchers want to see if it can be useful in patients with memory problems after TBI.
Objective:
To see how repetitive transcranial magnetic stimulation can be used to improve the connections between parts of the brain and whether this will lead to changes in memory.
Eligibility:
Adults 18-50 years old with TBI who can speak and write in English.
Healthy volunteers the same age and English ability.
Design:
Participants will be screened with a neurological exam and may have a urine pregnancy test.
Participants with TBI will have 7-15 visits. Healthy volunteers will have 2-8 visits.
At the visits, participants will have all or some of the following:
- MRI for about 1 hour. Participants will lie in a machine that takes pictures in a magnetic field. Participants will do some memory tasks.
- Memory and attention tasks with pictures and with a computer
- Questions about their mental state and well-being
- TMS: A wire coil is held on the scalp and a short electrical current passes through it. Participants will hear a click and feel a pulling or twitch. They may be asked to make simple movements. rTMS is repeated magnetic pulses in short bursts. They will have this for about 20 minutes.
A week after the last visit, some participants will return for a memory test.
详细描述
Objective
To use resting state functional connectivity (FC) as a biomarker of synaptic modulation by repetitive transcranial magnetic stimulation (rTMS) in paradigms intended to improve memory and learning. Ancillary outcomes include the effects of rTMS on the interaction between the explicit implicit memory systems.
Study population: Healthy adult volunteers
Design: The study contains two experiments. Experiment 1 is designed to establish the number of rTMS sessions required to produce a meaningful change in resting parieto-hippocampal FC in healthy subjects. Experiment 2 will replicate a prior experiment which used rTMS to enhance the explicit memory system in healthy subjects, and look for potential effects on the implicit system. This intervention will be contrasted with a negative control condition (vertex stimulation) in a between-groups design.
Outcome measures: The primary outcome measure is the change in FC produced by serially applied rTMS and improvement in explicit memory. We will explore whether enhancement of the explicit system has effects on resting state connectivity in the implicit system and whether white matter integrity predicts changes in FC in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experiments 1 and 2:
- •Healthy individuals
- •Age 18-50 (inclusive)
- •English speaking and writing
- •Experiment 3:
- •Age 18-50 (inclusive)
- •English speaking and writing
- •History of mild to moderate TBI
- •Performance 1 standard deviation below age-adjusted population norms on the
- •CVLT-2 within the past year from the date of visit.
排除标准
- •Any current major neurological or psychiatric disorder such as (but not limited to) stroke, Parkinson disease, Alzheimer disease, schizophrenia or major depression
- •History of seizure
- •Medications acting on the central nervous system
- •Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body
- •Implanted cardiac pacemaker or auto-defibrillator or pump
- •Non-removable body piercing
- •Claustrophobia
- •Inability to lie supine for 1 hour
- •Pregnancy, nursing, or plans to become pregnant during the study.
- •Members of the NINDS Behavioral Neurology Unit (BNU)
- •For Experiment 2: Participation in Experiment 1
研究组 & 干预措施
Experiment 2 - Parietal Cortex rTMS stimulation - 3 days
Experiment 2
干预措施: rTMS (Device)
Parietal Cortex rTMS stimulation - 1 day
Experiment 1
干预措施: rTMS (Device)
Parietal Cortex rTMS stimulation - 3 days
Experiment 1
干预措施: rTMS (Device)
Parietal Cortex rTMS stimulation - 4 days
Experiment 1
干预措施: rTMS (Device)
Experiment 2 - Vertex rTMS stimulation - 3 days
Experiment 2
干预措施: rTMS (Device)
Experiment 2 - Prefrontal Cortex rTMS stimulation - 3 days
Experiment 2
干预措施: rTMS (Device)
结局指标
主要结局
Functional Connectivity (FC) Changes Between the Left Hippocampus and Left Parietal Cortex
时间窗: Changes are calculated before and the day after rTMS
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at sufficient intensity to trigger action potentials in nearby neurons.The motor threshold is defined as the minimum percentage of the stimulator output to elicit a motor evoked potential. Repetitive TMS (rTMS) was delivered at 100% of the motor evoked potential threshold with repeated magnetic pulses at a frequency of 20 Hz. Functional MRI (fMRI) measures the change in oxygenated blood in the brain; at rest these levels fluctuate over time. These fluctuations can be similar between different parts of the brain. FC is the similarity in fluctuations of these fMRI signals and suggest how strongly two regions communicate with each other. We measured how TMS can change FC between specific areas of the brain. A positive score suggests a stronger communication between regions of the brain.
Associative Memory Test Score Changes
时间窗: Changes are calculated before and the day after rTMS and before and 7-14 days after rTMS
Participants studied 20 face-word pairs, and after a short delay, were required to recall the word associated with each pair. The number of correctly remembered pairs was recorded. rTMS was administered over different regions of the brain over 3 days. The Associative Memory test was administered at baseline (within a week before the first rTMS session), 1 day after the last rTMS session, and again 7-14 days after the last rTMS session. We calculated improvements on this task by subtracting the number of successfully remembered pairs 1 day after stimulation from the number remembered at baseline ("Changes one day after rTMS"). We also calculated whether these improvements lasted longer by subtracting the number of successfully remembered pairs 7-14 days after stimulation from the number remembered at baseline ("Changes 7-14 days after rTMS"). Positive scores represent increases in associative memory.
次要结局
- Implicit Weather Prediction Task (WPT)(Changes are calculated before and the day after rTMS, and before and 7-14 days after rTMS)