Noninvasive Neuromodulation of the Subjective Value Network in Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients.
研究概览
简要总结
Study Description:
This is an outpatient pilot study of the feasibility and tolerability of transcranial magnetic stimulation, directed to the network of brain regions responsible for assigning value to events, in patients with chronic pain. The primary hypothesis is that this study intervention will be feasible and tolerated well. The secondary hypothesis is that such study intervention will reduce the severity of chronic pain.
Objectives:
Primary Objective:
To establish the feasibility and tolerability of multi-day TMS in chronic pain patients.
Secondary Objective:
To obtain preliminary information on whether network-targeted TMS changes chronic pain ratings.
Exploratory Objectives:
To evaluate effects of study intervention on moment-to-moment pain and emotional experience, continuous actigraphy, HEAL Core Common Data Elements, and, when fMRI is feasible, resting state functional connectivity before and after study intervention blocks.
Endpoints:
Primary Endpoint:
Completion of at least two consecutive study intervention blocks, including one real on-target stimulation block and one off-target control stimulation block.
Secondary Endpoint:
Mean change in self-rated pain on the McGill Pain Questionnaire-Short Form after real on-target study intervention blocks compared with off-target control blocks.
Exploratory Endpoints:
Mean changes in Ecological Momentary Assessment, actigraphy, HEAL Core Common Data Elements, and, when fMRI is feasible, resting state functional connectivity after real on-target stimulation blocks compared with off-target control blocks.
详细描述
Study Description:
This is an outpatient pilot study of the feasibility and tolerability of transcranial magnetic stimulation, directed to the network of brain regions responsible for assigning value to events, in patients with chronic pain. The primary hypothesis is that this study intervention will be feasible and tolerated well. The secondary hypothesis is that such study intervention will reduce the severity of chronic pain.
Objectives:
Primary Objective:
To establish the feasibility and tolerability of multi-day TMS in chronic pain patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Participant must be willing to comply with all study procedures and be available for the duration of the study.
- •Male and female patients of 18 years of age or older.
- •Diagnosed with peripheral or central neuropathic pain of at least three months duration and phenotyped by the PRC under protocol 16-AT-0077, and on a stable pain medication regimen
- •In stable health as determined by study personnel, and without acute medical or mental illness for the past six weeks
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Concurrent epilepsy or history of seizure in the last year
- •Inability to provide informed consent
- •Ferromagnetic metal in the cranial cavity or eye, implanted neural stimulator, cochlear implant, or ocular foreign body
- •Implanted electronics contraindicated for MRI or TMS, such as cardiac pacemaker or auto-defibrillator or pumps
- •Non-removable body piercings
- •Claustrophobia severe enough to preclude MRI
- •Inability to lie supine for 1 hour
- •Members of the NINDS BNU or NIHPRC
- •Individuals with elevated risk and potential contraindications to MRI, as defined by the NIH NMR center guidelines.
- •Known hearing loss, as assessed by asking the potential participant whether they have hearing loss
- •Have difficulties with communication that make subjective pain assessment impossible or unreliable
- •Have active medical or psychiatric health issues that create additional and substantial adverse risks related to study procedures
- •Pregnant participants or participants planning to become pregnant during the study. At enrollment/baseline, pregnancy status will be assessed by asking participants capable of becoming pregnant whether they are pregnant or planning to become pregnant during the study. Before each fMRI, participants capable of becoming pregnant must have a negative urine pregnancy test to continue with the fMRI.
研究组 & 干预措施
Sequence A
Real on-target > off-target control > off-target control > real on-target
干预措施: Transcranial magnetic stimulation (Device)
Sequence A
Real on-target > off-target control > off-target control > real on-target
干预措施: Sham (Other)
Sequence B
Sequence B = off-target control > real on-target > real on-target > off-target control.
干预措施: Transcranial magnetic stimulation (Device)
Sequence B
Sequence B = off-target control > real on-target > real on-target > off-target control.
干预措施: Sham (Other)
结局指标
主要结局
To evaluate the tolerability and feasibility of transcranial magnetic stimulation in chronic pain patients.
时间窗: 36 months
Successful completion of targeting MRI and a 3-day course of stimulation.
次要结局
- To measure effects on pain, using an N-of-1 design and cross-sectional and continuous measures(36 months)