Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Proprioception
研究概览
简要总结
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
详细描述
Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations
- improved understanding of interindividual sacral nerval anatomy
- improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins)
- prediction of neural activation by sacral neuromodulation and improvement of response rates
- mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms)
- improvement of therapeutic efficacy in comparison to non-guided implantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent of patient and care taker
- •gastrointestinal motility disorder, disregarding underlying diseases
- •exclusion of mechanical obstructions in the gastrointestinal passage
- •age between 3 and 18
排除标准
- •pregnancy/breast feeding
- •decreased renal or thyroidal function
- •drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
- •contradictions for MRI
- •indication for analgosedation for MRI
- •inflammatory bowel diseases
- •fractures/different anatomy in sacral region
- •presence of cardiac pacemakers
研究组 & 干预措施
SNM
SNM implantation based on general knowledge and adult measurements
SNM-guided implantation
Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing
干预措施: SNM/MRI/EMG (Procedure)
结局指标
主要结局
Proprioception
时间窗: Within 12 weeks of sacral neuromodulation
Changes in the proprioception of urge to defecate, assessed by specialized questionnaires for patients and parents and analyzed per day (scale normal urge to defecate without soiling/encopresis; rare urge to defecate with soiling/encopresis; no urge to defecate with soiling/encopresis)
Fecal incontinence
时间窗: Within 12 weeks of sacral neuromodulation
Changes in the frequency and intensity of fecal incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified as soiling/encopresis)
Abdominal pain
时间窗: Within 12 weeks of sacral neuromodulation
Changes in the frequency and intensity of abdominal pain, , assessed by specialized questionnaires for patients and parents (NRS scale, 0 no pain - 10 maximum pain) and analyzed as episodes per day
Defecation frequency
时间窗: Within 12 weeks of sacral neuromodulation
Changes in defecation frequency per week, assessed by specialized questionnaires for patients and parents (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified regarding consistency based on Bristol Stool Scale (1 hard stool - 7 fluid stool))
Urinary incontinence
时间窗: Within 12 weeks of sacral neuromodulation
Changes in frequency and intensity of urinary incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week)
次要结局
未报告次要终点
研究者
Dr. med. Sonja Diez
Managing senior physician of Pediatric Surgery, University Hospital Erlangen, and PI of SMART-GUT
Friedrich-Alexander-Universität Erlangen-Nürnberg