Pain Alleviation for Patients Receiving Directional Deep Brain Stimulation to Treat Neuropathic Dental Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pain Severity Measured by Visual Analogue Scale (VAS)
研究概览
简要总结
This prospective observational study will evaluate pain outcomes in patients with neuropathic dental pain (Atypical Odontalgia/Phantom Tooth Pain) who undergo directional deep brain stimulation (DBS). Participants will complete validated pain, disability, quality-of-life, and mood assessments before surgery and following DBS programming. Directional stimulation will be applied to different thalamic targets to determine whether specific stimulation settings are associated with greater pain relief. The study aims to characterize changes in pain and quality of life following DBS and to identify the stimulation target associated with the greatest reduction in neuropathic dental pain.
详细描述
Neuropathic dental pain, also known as Atypical Odontalgia (AO) or Phantom Tooth Pain (PTP), is a chronic pain condition characterized by persistent tooth or facial pain in the absence of identifiable dental pathology. The condition is thought to result from injury to peripheral nerve structures that leads to alterations in central pain processing. Standard treatments, including antidepressants, neuroleptic medications, local anesthetic injections, corticosteroids, and nerve blocks, may provide relief for some patients; however, a subset of patients continue to experience debilitating pain despite these interventions.
Deep brain stimulation (DBS) is an established neurosurgical therapy for several neurological disorders and has been used off-label for the treatment of chronic neuropathic pain. Previous studies suggest that stimulation of thalamic structures involved in pain processing, including the ventral posteromedial nucleus (VPM), centromedian nucleus (CM), and anterior pulvinar (aPu), may provide pain relief for neuropathic facial pain. However, no established DBS target currently exists for neuropathic dental pain.
This prospective observational study will evaluate pain outcomes in patients with neuropathic dental pain who undergo directional DBS. Directional DBS leads will be implanted in a location that permits stimulation of the VPM, CM, and aPu regions of the thalamus. Following surgery, participants will undergo routine clinical programming during which stimulation settings will be systematically adjusted to direct stimulation toward each target region, as well as ring-mode stimulation and an off-stimulation condition. Participants will remain blinded to the stimulation settings.
Participants will complete validated measures of pain, pain-related disability, quality of life, and depressive symptoms before surgery and after completion of the programming period. Visual Analog Scale (VAS) pain ratings will also be collected following each stimulation condition to evaluate differences in pain relief between targets. The primary objective is to assess changes in pain levels associated with different stimulation settings and identify the stimulation target associated with the greatest reduction in neuropathic dental pain. Secondary objectives include evaluating changes in pain-related disability, quality of life, and mood following DBS treatment.
The findings from this study will provide preliminary evidence regarding optimal thalamic stimulation targets for neuropathic dental pain and may inform future research and treatment approaches for patients with this challenging and currently underserved condition.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 to 80 years.
- •Diagnosis of Atypical Odontalgia (AO) (also known as neuropathic dental pain).
- •Receiving deep brain stimulation (DBS) treatment for AO due to inadequate response to conventional therapies, including: Pharmacological therapies, and/or Local anesthetics, corticosteroid injections, or nerve blocks.
- •Able and willing to provide informed consent.
排除标准
- •Refusal or inability to provide informed consent.
- •Known major depression.
- •Acute psychosis.
结局指标
主要结局
Pain Severity Measured by Visual Analogue Scale (VAS)
时间窗: Baseline (pre-operative); after each 2-week stimulation period during the 10-week post-activation programming phase; and 3 months after completion of the randomized stimulation period.
Pain severity will be assessed using the Visual Analogue Scale (VAS). Participants will complete the VAS following two weeks on each of five stimulation settings (ring mode, VPM, aPu, CM, and off stimulation). The primary outcome is the comparison of VAS scores across stimulation settings to identify the setting associated with the greatest pain reduction.
次要结局
- Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)(Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.)
- Change in Pain-Related Disability Assessed by the Pain Disability Index (PDI)(Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.)
- Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Survey (SF-36)(Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.)
- Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)(Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.)
- Change in Pain Severity Assessed by the Visual Analogue Scale (VAS)(Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.)
研究者
Christopher Honey
N
University of British Columbia