Transcranial Magnetic Stimulation to Enhance Cortical Hippocampal Functional Connectivity as a Novel Means for Relieving Chronic OA Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain ratings (Numeric Rating Scale)
研究概览
简要总结
In this study the investigators aim to examine the effects of Transcranial Magnetic Stimulation (TMS) on hippocampal network connectivity and pain levels in individuals with pain due to knee osteoarthritis.
详细描述
Osteoarthritis (OA) pain is one of the most prevalent causes of chronic pain worldwide. Symptoms can last from months to a lifetime, severely impacting patients' quality of life. New strategies - including non-invasive brain stimulation techniques - have shown promise for sustained pain relief, yet evidence on their reliability and efficacy is limited. Apkarian et. al have previously shown that the dorsal hippocampus plays a central role in pain analgesia; thus, the study aim is to test whether non-invasively enhancing dorsal hippocampus activity is a useful new strategy for pain relief in knee OA patients. This study will recruit 35 patients with chronic OA pain for > 6 months. Each participant will receive 3 rounds of different treatment modalities in a cross-over manner. Each treatment modality will consist of 5 daily consecutive rTMS sessions followed by a 2-weeks wash-out period. Questionnaires will be completed prior to and following each intervention, and after each treatment round. Participants will be trained to use a pain electronic application (smartphone-based tool to rate pain intensity and mood on NRS scales, as well as indicate rescue medication use, developed in our lab). They will be asked to use this application for 7-10 days prior to the first round of intervention and during the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 months of knee pain on a daily basis;
- •male or female with no racial or ethnic restrictions;
- •18 to 75 years old;
- •average knee pain intensity > 4/10 at study entry;
- •must be able to read, understand, and sign consent form;
- •generally healthy.
- •able to use the PainApp
排除标准
- •rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- •Chronic neurologic conditions, e.g., Parkinson's
- •other severe medical diseases;
- •pregnancy;
- •positive urinary screen for any recreational drugs,
- •opioids use;
- •use of anticoagulants (low dose ASA allowed);
- •history of gastric ulcer; renal insufficiency or congestive heart failure,
- •contraindication to MRI,
- •contraindication to TMS; including history of seizure/epilepsy*
- •Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- •In the judgment of the investigator, unable or unwilling to follow protocol and instructions.
- •Diagnosis of major depression.
结局指标
主要结局
Pain ratings (Numeric Rating Scale)
时间窗: Pain ratings immediately after each rTMS modality and effects after the end of stimulation round (1 week).
The primary efficacy outcomes are the effects of the rTMS modalities on pain app ratings.
次要结局
- Pain trajectories(1 to 12 weeks (end of the study))
- Adverse events(1 to 12 weeks (end of the study))
- Brain biomarkers and psychological indicators of rTMS effects and pain relief(1 to 12 weeks (end of the study))
- Global impression of change(1 to 12 weeks - after each rTMS round.)
研究者
Apkar Apkarian
Director Center for Translational Pain Research, Director Center of Excellence for Chronic Pain and Drug Abuse Research, Professor of Neuroscience, Anesthesia, PM&R
Northwestern University