Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.

Официальное название

Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson's Disease Patients: a Randomized, Double-blind Clinical Trial

Обзор

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.

Подробное описание

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients. Meanwhile, the investigators aimed to verify mechanistic effects by investigating changes in proteins and cytokines related to inflammation and intestinal barrier function in serum and feces to verify mechanistic effects.

Вмешательства

• Устройство active Transcutaneous auricular vagus nerve stimulation
  Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.
• Устройство sham Transcutaneous auricular vagus nerve stimulation
  In the sham stimulation group, the electrodes were fixed at the left earlobe with the same stimulus parameters. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.

Первичные конечные точки

• alterations in complete spontaneous bowel movements per week (CSBMs/week) [Срок оценки: Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention]

Вторичные конечные точки (12)

• Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) at one day post intervention [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline Gastrointestinal Symptoms Rating Scales at one day post intervention [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline constipation symptoms scores at one day post intervention [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline Patient Assessment of Constipation Quality of Life scale，PAC-QOL at one day post intervention [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline HRAM at one day post intervention--Resting pressure (mmHg) [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline HRAM at one day post intervention--maximum squeeze pressure (mmHg) [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline HRAM at one day post intervention--First sensation (mL) [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline HRAM at one day post intervention--desire to defecate threshold [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline HRAM at one day post intervention--maximum tolerance [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline gastrointestinal electrogram at one day post intervention--amplitude [Срок оценки: Assessed at baseline, one day post intervention]
• Change from Baseline gastrointestinal electrogram at one day post intervention--frequency [Срок оценки: Assessed at baseline, one day post intervention]

Критерии участия

Критерии включения

• aged 40-70 years;
• had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;
• fulfilled Rome IV criteria for functional constipation, including having < 3 spontaneous bowel movements (SBM; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months;
• stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.

Критерии исключения

• a history of previous abdominal surgery (other than appendectomy);
• the presence of carcinoma;
• any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury;
• taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors;
• a serious concomitant disease of the heart, liver, kidney, or diabetes;
• pregnancy or lactation;
• participating in another trial or enrolled in a trial during the past month;
• an allergic reaction to surface electrodes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06623591 · 2024-taVNS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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