Accelerated Theta Burst in Chronic Pain: A Biomarker Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the Brief Pain Inventory (BPI) score
研究概览
简要总结
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
- •Age 18 - 70
- •Right-handed
- •Agree to having fMRI scans as well as rTMS sessions
- •Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
- •Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
- •Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.
排除标准
- •History of MI, CABG, CHF, or other cardiac history.
- •Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
- •Pregnancy or breastfeeding
- •Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
- •Autism spectrum disorder
- •Inability to stop taking medication contraindicated with treatment
- •Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
- •A positive urine toxicology screen
结局指标
主要结局
Change in the Brief Pain Inventory (BPI) score
时间窗: Pre-treatment, immediately post-treatment
A self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of depression and individual is experiencing. Scoring: 1. Pain Severity Score: This is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. 2. Pain Interference Score: This is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Change in the McGill Pain Questionnaire score
时间窗: Pre-treatment, immediately post-treatment
A self-report questionnaire that allows individuals that assesses the quality and intensity of pain that is experienced. The pain rating index has 2 subscales: sensory subscale with 11 words, and affective subscale with 4 words. These items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain.
次要结局
- Change in teh Hamilton Rating Scale for Depression (HAM-17) score(Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment)
- Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI)(Pre-treatment, immediately post-treatment, 4 weeks post-treatment)
- Change in the Montgomery Asberg Depression Rating Scale (MADRS) score(Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment)
- Change in the Pain Catastrophizing Scale (PCS) score(Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment)
研究者
Nolan R
Assistant Professor of Psychiatry and Behavioral Sciences
Stanford University