Randomized Controlled Pilot Trial of Cereset Research For Chronic Nausea
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGY-SYM) scores
研究概览
简要总结
This study will explore the use of Cereset Research for symptoms associated with refractory chronic nausea in patients with gastroparesis (GP) in a randomized, clinical trial.
详细描述
Cereset Research (CR) is a noninvasive, close-loop, acoustic stimulation brain feedback system. CR translates brainwaves in real time, echoing them immediately via earbuds. This supports the brain to auto calibrate, self adjust, and relax (acoustic neuromodulation). The brain wave patterns are observed to shift towards improved balance and reduced hyperarousal, getting unstuck from what have become stuck patterns related to trauma and stress. Previous clinical trials using CR, as well as the legacy technology HIRREM, have shown significant benefit to reduce symptoms (stress, anxiety, depression, insomnia, Post-traumatic stress disorder (PTSD), persistent post-concussion symptoms, hot flashes, and others). Improved autonomic nervous system function has also been documented) heart rate variability and variable reflex sensitivity), as well as improved network connectivity on functional Magnetic resonance imaging (MRI) before and after the intervention.
Gastroparesis with normal gastric emptying, and associated chronic nausea, is a challenging clinical condition. There is associated autonomic dysfunction, along with many behavioral symptoms, and effective treatments are lacking. Based on prior studies, there is a reason to believe that CR may have beneficial effects for such patients. This controlled clinical trial will enroll up to 24 adults, age 18 or older, who have symptoms of chronic nausea (due to gastroparesis and who are not taking medications or supplements for management of symptoms) with a goal of 20 to complete the intervention. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 6 CR sessions over 4 weeks of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only and will serve as a control group. Participants in both groups will continue their other current care throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with chronic drug- refractory, nausea and vomiting (ages 18 and up)
- •Solid-phase gastric emptying studies show either normal gastric emptying or delayed gastric emptying
- •Referring physician will confirm eligibility based on Rome-IV criteria
- •Normal upper endoscopy or upper GI series and normal gallbladder tests
- •Stable gastrointestinal symptoms with total GCSI score of greater than or equal to 21
- •Ability to sign informed consent
- •Ability to comply with basic instructions and be able to sit still, comfortably during sessions
- •Willingness to complete the EGG and WLST
排除标准
- •Non-gastrointestinal disorders which could explain symptoms in the opinion of the investigator
- •Active H pylori infection
- •Significant hepatic injury (elevated ALT, AST, bilirubin)
- •Metabolic, mechanical, or mucosal inflammatory causes to explain GI symptoms such as inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
- •Patients with significant cardiac or cardiovascular disease, malignancy, or other comorbid conditions
- •Use of narcotics more than three days per week or other drugs that affect motility (that cannot be held)
- •Previous diagnosis or history of neurocardiogenic syncope, orthostatic hypotension, etc.
- •Patients with pace makers
- •Use of beta blockers which can interfere with heart rate variability recording
- •Unable, unwilling, or incompetent to provide informed consent/assent
- •Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1.5 hours
- •Severe hearing impairment (because the subject will be using ear buds during CR)
- •Anticipated and ongoing use of alcohol or recreational drugs
- •Weight is over the chair limit (400 pounds)
- •Currently enrolled in another active intervention research study
- •Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2)
- •Prior use of the following modalities within one month before enrollment: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS)
- •Known seizure disorder or unspecified seizure within the past 12 months
- •Thoughts of suicide within the last 3 months
结局指标
主要结局
Change in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGY-SYM) scores
时间窗: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)
The Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) is 20 items. This inventory includes six subscales of related GI distress including heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Individual item scores range from 0 (none) to 5 (very severe). The higher the score, the more severe the GI symptoms.
Change in Gastroparesis Cardinal Symptom Index (GCSI) scores
时间窗: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)
The Gastroparesis Cardinal Symptom Index (GCSI) is a 9-item scale within the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM).episodes). The severity of symptom response scale ranges from 0 ("none"), 1 ("mild"), 2 ("moderate"), 3 ("severe") to 4 ("very severe"). Score can range from 0 to 4. High scores reflect greater symptom severity.
次要结局
- Change in Nausea Profile (NP) scores(Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI))
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) scores(Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI))
- Change in Generalized Anxiety Disorder-7 (GAD-7) scores(Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI))