Идёт набор NCT06932783

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Без фазы С лечением Cirrhosis

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: Transcutaneous Electrical Acustimulation (TEA), Sham Transcutaneous Electrical Acustimulation (TEA).
Кому может быть актуально: Состояния в реестре: Cirrhosis. Базовые параметры: от 18 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

RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Обзор

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression. Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.

Вмешательства

Устройство Transcutaneous Electrical Acustimulation (TEA)
Participant will apply TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. The top electrode will be placed at ST36 (via acupuncture point) and the electrode patch will be placed vertically. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment (approximately 9-10 weeks).
Устройство Sham Transcutaneous Electrical Acustimulation (TEA)
Participant will apply sham TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. Sham TEA will be performed via one point on the leg and not on any meridian or acupoints that were used in previous gastrointestinal studies and did not yield any significant effects. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment (approximately 9-10 weeks)

Первичные конечные точки

Acceptability Questionnaire at 10 weeks [Срок оценки: 10 weeks]
Feasibility based on the proportion of participants enrolled that were contacted [Срок оценки: Enrollment period (2 years)]
Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in) [Срок оценки: Run-in (-14 days to baseline) to 10 weeks]
Feasibility based on time required to complete study assessments [Срок оценки: Screening - 10 weeks]
Proportion of questionnaires completed at baseline and the final study visit (10 weeks) [Срок оценки: Baseline, 10 weeks]
TEA usage during the intervention period [Срок оценки: Weeks 1-8 of TEA treatment]

Критерии участия

Критерии включения

Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol
Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for >50% of days within 3- months)
Depression (in at least half of participants) - must meet the criteria as outlined in the protocol
English speaking
Willing to use a Transcutaneous Electrical Acustimulation device