Actively Recruiting
Randomized, Double-Blind, Placebo-Controlled Trial of Transcranial Alternating Current Stimulation for Refractory Constipation and Somatic Symptom Disorder
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-09
60
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of transcranial alternating current stimulation (tACS) in adults who have refractory functional constipation along with somatic symptom disorder. This condition involves ongoing bowel problems despite usual treatments, frequent use of laxatives, and disrupted brain-gut communication contributing to persistent symptoms. The study aims to assess improvements in bowel function, symptom severity, quality of life, and the safety and tolerability of tACS compared to a placebo. Participants are randomly assigned to receive either active tACS or placebo stimulation. The tACS involves placing electrodes on the forehead and mastoid areas to target brain regions involved in bowel control, delivering alternating current at 15 mA and 77.5 Hz for 30 to 40 minutes daily over 4 weeks (20 sessions). The placebo group receives sham stimulation mimicking the procedure without sustained current. The study is double-blind with identical procedures for both groups. During the study, participants will track their bowel movements and complete questionnaires on constipation symptoms and quality of life. Researchers will monitor changes in bowel movement frequency, stool consistency, abdominal bloating, and psychological symptoms throughout the 4-week treatment and follow-up periods. Adverse events and patient tolerability will also be recorded. The main outcome is the proportion of patients who achieve an increase of at least one complete spontaneous bowel movement per week during treatment.
CONDITIONS
Brief 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 by Rome IV criteria
- 2 or fewer complete spontaneous bowel movements per week during 2-week screening
- Unsatisfactory response to at least 3 months of prior treatment including laxatives or prokinetics
- Diagnosis of somatic symptom disorder by DSM-5 criteria with symptoms lasting at least 6 months
- Age between 18 and 80 years
- No participation in other clinical trials during study period
- Voluntary informed consent provided
You will not qualify if you...
- Presence of organic diseases such as tuberculosis, polyps, Crohn's disease, tumors, or congenital megacolon
- Endocrine or metabolic disorders like hypothyroidism or diabetes
- Neurological disorders such as Parkinson's disease
- Long-term use of medications affecting intestinal function or causing constipation (except specified emergency meds)
- History of chronic pain or substance abuse including opioids
- Mental disorders treated with psychotropic or hormonal medications over 3 months prior to visit
- Risk of self-harm or suicide or requiring psychosomatic intervention
- Allergy or contraindications to psychiatric medications like fluoxetine
- Pregnant or breastfeeding women
- Benign or malignant tumors or autoimmune diseases
- Chronic conditions requiring long-term medication affecting quality of life or interfering with treatment, including cardiovascular, coagulation, liver, kidney diseases, organ failure, cognitive impairment, or aphasia
- Use of anticoagulants such as warfarin or heparin regularly during study period
- Participation in other clinical trials during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 consecutive weeks
Participants receive daily transcranial alternating current stimulation or placebo sessions targeting the prefrontal cortex and related brain-gut pathways to treat refractory constipation and somatic symptom disorder.
20 sessions (Monday to Friday, 30-40 minutes each)
Duration - 4 weeks
Participants are monitored for changes in bowel movement frequency, stool consistency, symptom severity, and quality of life after completing the stimulation sessions.
Weekly visits for up to 4 weeks
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.
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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