NCT07323407
Recruiting
Not Applicable
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 sites in 1 country60 target enrollmentStarted: August 20, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Xijing Hospital of Digestive Diseases
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 1-4 treatment week
Secondary Outcomes
- 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)
Investigators
Zhifeng Zhao, PhD
Principal Investigator
Xijing Hospital of Digestive Diseases
Study Sites (2)
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