Actively Recruiting
Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-09
60
Participants Needed
2
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of functional constipation according to Rome IV criteria
- Two or fewer complete spontaneous bowel movements per week during the 2-week screening period
- Dissatisfaction with prior constipation treatments after at least 3 months of therapy including laxatives
- Diagnosis of somatic symptom disorder per DSM-5, confirmed by clinical interview
- Presence of distressing somatic symptoms affecting daily life with persistent symptom-related thoughts, anxiety, or time spent on health concerns for at least 6 months
- Age between 18 and 80 years
- Not participating in other clinical trials during the study period
- Voluntary informed consent given
You will not qualify if you...
- Presence of organic diseases such as tuberculosis, polyps, Crohn's disease, tumors, or congenital megacolon
- Endocrine disorders like hypothyroidism or metabolic diseases such as diabetes or thyroid dysfunction
- Neurological disorders including Parkinson's disease
- Long-term use of medications affecting intestinal function or causing constipation, except prescribed emergency drugs during the trial
- History of chronic pain or substance abuse including opioids
- Mental disorders treated with psychotropic or hormonal medications for over 3 months before visit
- Risk of self-harm or suicide requiring psychiatric or psychosomatic intervention
- Allergy to psychiatric medications or contraindications to fluoxetine
- Pregnant or breastfeeding women
- Diagnosis of benign or malignant tumors or autoimmune diseases
- Chronic illnesses requiring long-term medication that affect quality of life or interfere with treatment, including cardiovascular, coagulation, liver, kidney, cognitive, or speech disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
2
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Z
Zhifeng Zhao, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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