Network Control and Functional Context: Mechanisms for TMS Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance
研究概览
简要总结
This study uses different types of functional magnetic resonance imagining (fMRI) to generate individual transcranial magnetic stimulation (TMS) targets. During the TMS/fMRI imagining sessions, the investigators stimulate a target of either high or low regional controllability during a working memory task to investigate network responses and the impact of TMS on behavior.
详细描述
This study involves up to 4 visits for patients with Attention Deficit Hyperactivity Disorder (ADHD) and 5 visits for non-symptomatic subjects.
Visit 1 has both remote and in-person procedures. The remote part of visit 1 will consist of a consenting and extended screening visit. The in-person procedures of visit 1 will be scheduled for the same day as visit 2. Before visit 2, the investigators will demonstrate TMS to make sure participants can tolerate the stimulation.
Visit 2 consists of an hour-long baseline MRI Scan along with an assessment session. The baseline MRI scan is used to find individualized TMS targets. The assessment session of visit 2 will be done over a video call. During the video call, the investigators will have the participant complete some computerized tasks and assessments.
Visit 3 will be a 1-hour long TMS/fMRI session, where the participant will complete a working memory task twice while single pulse TMS is being delivered. In between the 2 rounds of the working memory task, the participant will receive 4 minutes of repetitive stimulation.
Non-symptomatic subjects will have a fourth visit that mirrors visit 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
This study will use a single-blind design.
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-28 years old
- •Right-handed
- •No history of schizophrenia or bipolar disorder
- •No history of neurological illness
- •Healthy participants: no history of any mental illness
- •ADD/ADHD Participants; Diagnosed with ADD/ADHD
- •ADD/ADHD: Ability to refrain from stimulant medication within 24 hours of study sessions
- •For participants reporting daily use of more than 400mg caffeine/ day: willing to lower down to this level at least 1 week prior to screening visit and maintain throughout study visits
排除标准
- •Unable to have an MRI scan
- •Unable to receive or tolerate TMS
- •Pregnant, nursing, or trying to become pregnant (self-attestation alone)
- •History of stoke, epilepsy, or brain scarring
- •Healthy participants: psychoactive medication use
- •Healthy participants: first degree relative with psychosis
- •ADHD participants: inability to refrain from stimulant medication within 23 hours of study sessions
- •Active suicidality or current suicidal risk as determined by the investigator
- •Any medication that interferes with fMRI recordings as per PI discretion
- •Otherwise determined by investigator to be unfit for study
研究组 & 干预措施
Low controllability TMS target in non-symptomatic participants
We will administer TMS to an individualized target of low regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
High regional controllability TMS target in non-symptomatic participants
We will administer TMS to an individualized target of high regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
High regional controllability TMS target in non-symptomatic participants
We will administer TMS to an individualized target of high regional controllability while non-symptomatic participant completes a working memory task inside the MRI scanner.
干预措施: High controllability TMS target (Procedure)
High regional controllability TMS target in ADHD participants
We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.
干预措施: Transcranial Magnetic Stimulation (TMS) (Device)
High regional controllability TMS target in ADHD participants
We will administer TMS to an individualized target of high regional controllability while patient completes a working memory task inside the MRI scanner.
干预措施: High controllability TMS target (Procedure)
结局指标
主要结局
Effect of Single TMS Pulses to a High vs. Low Regional Controllability Target on Working Memory Task Performance
时间窗: Up to 3 weeks
Control participants complete two visits in which they undergo functional MRI interleaved with TMS targeting a specific controllability region. Each visit involves administering single pulses of TMS while participants perform a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while completing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high regional controllability target and the other stimulating a low regional controllability target. The effect of single-pulse TMS on N-back task performance will be assessed before rTMS administration using percent accuracy scores. Percent accuracy reflects the percentage of correct trials out of the total Nback trials, with higher scores indicating better task performance.
Effect of rTMS on Working Memory Task Performance
时间窗: Pre- and post-TMS at visits 3 (approximately day 7) and 4 (approximately day 14)
Control participants complete two visits with functional MRI interleaved with TMS targeting a specific controllability region. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted controllability region is counterbalanced, with one visit stimulating a high controllability target and the other a low controllability target. The effect of rTMS on N-back task performance will be assessed by comparing participants' percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS. Percent accuracy, indicating the percentage of correct trials, will be analyzed for both high and low regional controllability targets across the visits.
Effect of rTMS to High vs. Low Controllability Target on Working Memory Task Performance
时间窗: Up to 3 weeks
Control participants complete two visits where they undergo functional MRI interleaved with TMS targeting specific brain controllability regions. Each visit includes single pulses of TMS during a working memory task (N-back), followed by a brief round of repetitive TMS (rTMS), and concluding with another set of single pulses while performing the N-back task. The targeted brain region is counterbalanced across visits, with one visit stimulating a high controllability target and the other a low controllability target. In order to compare the effect of rTMS to high versus low controllability targets on working memory performance, we will assess the change in N-back task percent accuracy scores before (pre-rTMS) and after (post-rTMS) rTMS to both regions. A greater percent change (positive value) means improved task performance following rTMS.
次要结局
- Effect of rTMS on Working Memory Performance in Participants With ADHD(Pre- and post-TMS at visit 3 (approximately day 7))