Идёт набор NCT07411859

Reboot Pain (tDCS)

Без фазы С лечением Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Transcranial Direct Current Stimulation.
Кому может быть актуально: Состояния в реестре: Chronic Pain. Базовые параметры: 18 лет — 89 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Reboot Pain: Integrating Neuromodulation Into Clinical Care for Military and Veterans With Chronic Pain

Обзор

This study will examine the effectiveness of tDCS (Transcranial Direct Current Stimulation) in reducing chronic pain when used with Emory Healthcare Veterans Program (EHVP)-ABHP (Accelerated Behavioral Health Program) participants as measured by the Pain, Enjoyment of Life and General Activity Scale (PEG).

Подробное описание

This study protocol will test whether a non-drug brain stimulation method called Transcranial Direct Current Stimulation (tDCS) can help reduce chronic pain in military service members and veterans who are receiving mental health treatment through the Accelerated Behavioral Health Program (ABHP) at the Emory Healthcare Veterans Program (EHVP). The goal is to see if combining tDCS treatment with standard therapy will improve pain and overall well-being.

The study population will include adult service members and veterans aged 18-89 who are experiencing chronic pain and enrolled in the Accelerated Behavioral Health Program (ABHP) for mental health care. The study will not include minors, prisoners, non-English speakers, or pregnant individuals, as well as those with certain medical contraindications.

Participants will receive short (\~20 minute), daily tDCS treatment sessions for two weeks. tDCS is a non-invasive method delivering a weak electrical current to specific areas of the brain to help reduce pain signals. Participants will complete brief daily pain surveys, questionnaires, and standard clinical interviews. The tDCS sessions will either take place in person at Emory's Executive Park Clinic or virtually with assistance as needed.

Participants will receive active tDCS treatment for two weeks and standard of care follow-up assessments at the 3, 6, and 12 month marks after treatment.

Participants will be recruited from those patients already entering or a part of the Emory Healthcare Veterans Program (EHVP) in Atlanta, Georgia.

The total enrollment for this study is up to 100 participants over the course of two years. It is expected that some individuals may not qualify after screening or will withdraw early. No specimens or biological samples will be stored for future research use. Data collected in the study will be de-identified and only used for this protocol.

Participants will review and sign an electronic consent form using a secure online system before active participation in the study. The consent form ensures participants fully understand the study, and they can withdraw at any time without penalty.

Вмешательства

Устройство Transcranial Direct Current Stimulation
tDCS is a painless brain stimulation treatment that uses direct electrical currents (at a constant, low intensity level) to stimulate specific parts of the brain and help modulate neuronal activity. Participants will receive a series of tDCS treatments during the Accelerated Brain Health Program (ABHP) coupled with self-report of pain severity and interference tDCS has been used to improve cognitive functions and pain management. Starting Day 1 of EHVP-IOP, tDCS will be administered with a const

Первичные конечные точки

Change in PEG (Pain, Enjoyment of Life and General Activity) scale [Срок оценки: Baseline, day 12 post-intervention (end of treatment)]

Вторичные конечные точки (1)

Change in PEG scale [Срок оценки: Baseline, 3,6, and 12 months post-intervention]

Критерии участия

Критерии включения

Male or Female, 18-89 years old
Treated on site for ABHP
Willing to self-administer tDCS and complete the measures
PEG pain intensity of 4 or more for most of the day at least 3 days per week
Have an established PCP (Primary Care Provider) or pain management provider

Критерии исключения

Implanted pacemaker
Seizure Disorder
Pregnancy, if applicable
Any new onset of the following:

Balance Problems
Difficulty walking
Bladder incontinence
Bowel incontinence
Numbness
Tingling
Weakness
Medical contraindications

Current use of sodium channel blockers
Lidocaine (OTC/transdermal delivery is ok)
Mexiletine
Amitriptyline; other tricyclic antidepressants
Anti-epileptic medications: phenytoin, carbamazepine, lamotrigine, oxcarbazepine, rufinamide, lacosamide and eslicarbazepine acetate