NCT07323407招募中不适用
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder
Xijing Hospital of Digestive Diseases2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The proportion (%) of patients who achieved an increase of ≥1 CSBM per week compared to baseline for at least 2 out of the 4 treatment weeks.
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.
The study focuses on three primary domains:
Efficacy - Bowel Function:
• Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.
Efficacy - Symptom and Quality of Life Burden:
• Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).
Safety and Tolerability:
• Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.
- •Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.
- •Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).
- •Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.
- •Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.
- •Criterion B: At least one of the following must be met:
- •Excessive and persistent thoughts about the severity of symptoms;
- •Persistently high levels of anxiety about health or symptoms;
- •Excessive time and energy devoted to health concerns or symptoms.
- •Criterion C: Symptoms must persist for at least 6 months.
- •Age Range: Subjects must be between 18 and 80 years old.
- •No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period.
- •Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form.
排除标准
- •Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);
- •Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);
- •History of chronic pain or substance abuse, such as opioids;
- •Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;
- •Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;
- •History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver/kidney impairment or prolonged Q-T interval on ECG;
- •Pregnant or breastfeeding women;
- •Patients with benign or malignant tumors or autoimmune diseases;
- •Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations/treatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use (warfarin/heparin), liver/kidney diseases, organ failure, cognitive impairment, aphasia, etc.
结局指标
主要结局
The proportion (%) of patients who achieved an increase of ≥1 CSBM per week compared to baseline for at least 2 out of the 4 treatment weeks.
时间窗: 1-4 treatment week
次要结局
- Proportion of participants achieving an increase of ≥1 CSBM from baseline in at least 2 weeks during follow-up(Weeks 1-4 follow-up; assessed over the 4-week period)
- Change from baseline in weekly frequency of spontaneous bowel movements (SBM)(Baseline and each week during Weeks 1-4)
- Change from baseline in weekly frequency of complete spontaneous bowel movements (CSBM)(Baseline and each week during Weeks 1-4)
- Change from baseline in stool consistency (Bristol Stool Form Scale) for weekly SBMs(Baseline and Weeks 3-4)
- Change from baseline in straining score for weekly SBMs (4-point scale: 0=no difficulty, 1=mild, 2=moderate, 3=severe)(Baseline and Weeks 3-4)
- Change from baseline in abdominal bloating severity (5-point scale: 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe)(Baseline and Weeks 3-4)
- Change from baseline in Patient Health Questionnaire-9 (PHQ-9) score(Baseline and Week 4)
- Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score(Baseline and Week 4)
- Change from baseline in Patient Health Questionnaire-15 (PHQ-15) somatic symptom score(Baseline and Week 4)
- Change from baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL)(Baseline and Week 4)
- Proportion of participants using polyethylene glycol (PEG) as rescue medication(During the 4-week treatment period)
研究者
Zhifeng Zhao, PhD
Principal Investigator
Xijing Hospital of Digestive Diseases
研究点 (2)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes MellitusNCT07282743Sun Pharmaceutical Industries Limited285
招募中
2 期
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal SurgeryNCT07311369Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.40
招募中
3 期
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)Cold UrticariaNCT07266402Celldex Therapeutics240
已完成
1 期
Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic RhinitisRhinitis AllergicNCT07317960Kazakh National Agrarian University30
尚未招募
2 期
Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile DysfunctionErectile DysfunctionNCT07311330Beijing Inno Medicine Co., Ltd.40