Neuropathic Dental Pain & DBS
Pain Alleviation for Patients Receiving Directional Deep Brain Stimulation to Treat Neuropathic Dental Pain
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Danielle Pietramala
- Номер телефона: 68396 604-875-4111
- Электронная почта: danielle.pietram@ubc.ca
Места учебы
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British Columbia
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Vancouver, British Columbia, Канада, V5Z1M9
- Рекрутинг
- Vancouver General Hospital
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Контакт:
- Danielle Pietramala
- Номер телефона: 6043495059
- Электронная почта: d.pietramala@hotmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- Known major depression.
- Acute psychosis.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Ring-Mode Stimulation
Participants receive DBS ring-mode stimulation, allowing current to spread across the target region encompassing the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), and centromedian nucleus (CM).
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Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system.
Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off.
Participants will undergo each stimulation condition in a randomized sequence.
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Экспериментальный: Ventral Posteromedial Nucleus (VPM) Stimulation
Participants receive directional DBS stimulation targeted toward the ventral posteromedial nucleus (VPM) of the thalamus.
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Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system.
Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off.
Participants will undergo each stimulation condition in a randomized sequence.
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Экспериментальный: Anterior Pulvinar (aPu) Stimulation
Participants receive directional DBS stimulation targeted toward the anterior pulvinar (aPu) of the thalamus.
|
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system.
Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off.
Participants will undergo each stimulation condition in a randomized sequence.
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Экспериментальный: Centromedian Nucleus (CM) Stimulation
Participants receive directional DBS stimulation targeted toward the centromedian nucleus (CM) of the thalamus.
|
Participants will receive standard-of-care directional deep brain stimulation (DBS) using an implanted DBS system.
Stimulation will be delivered using ring-mode stimulation, directional stimulation toward the ventral posteromedial nucleus (VPM), anterior pulvinar (aPu), or centromedian nucleus (CM), or with stimulation turned off.
Participants will undergo each stimulation condition in a randomized sequence.
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Без вмешательства: Stimulation Off
Participants have the DBS device turned off and serve as a control condition for comparison with active stimulation settings.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Severity Measured by Visual Analogue Scale (VAS)
Временное ограничение: 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.
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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.
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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.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Pain Severity Assessed by the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Временное ограничение: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Pain characteristics and severity will be assessed using the SF-MPQ-2.
Changes from baseline to follow-up will be evaluated.
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Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Change in Pain-Related Disability Assessed by the Pain Disability Index (PDI)
Временное ограничение: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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The impact of pain on daily functioning will be measured using the Pain Disability Index.
Changes from baseline to follow-up will be evaluated.
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Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Survey (SF-36)
Временное ограничение: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Health-related quality of life will be measured using the SF-36 questionnaire.
Changes from baseline to follow-up will be evaluated.
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Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Change in Depressive Symptoms Assessed by the Beck Depression Inventory (BDI)
Временное ограничение: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Depressive symptoms will be measured using the Beck Depression Inventory.
Changes from baseline to follow-up will be evaluated.
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Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Change in Pain Severity Assessed by the Visual Analogue Scale (VAS)
Временное ограничение: Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Overall pain intensity will be compared between baseline and follow-up while participants are maintained on their optimal stimulation setting.
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Baseline (pre-operative) and 3 months after completion of the randomized stimulation period.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- H24-01903
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .