Could zapping the brain relieve stubborn constipation?
NCT ID NCT07323407
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive brain stimulation technique called tACS can help people with severe constipation that hasn't improved with standard treatments, especially when they also have stress-related physical symptoms. About 60 adults will receive either real or sham tACS sessions over 4 weeks. Researchers will track changes in bowel movements, symptom severity, and quality of life to see if this brain-targeted approach offers relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria. 2. Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week. 3. 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). 4. 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: 1. Excessive and persistent thoughts about the severity of symptoms; 2. Persistently high levels of anxiety about health or symptoms; 3. Excessive time and energy devoted to health concerns or symptoms. * Criterion C: Symptoms must persist for at least 6 months. 5. Age Range: Subjects must be between 18 and 80 years old. 6. No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period. 7. Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form. Exclusion Criteria: 1. 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); 2. 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); 3. History of chronic pain or substance abuse, such as opioids; 4. 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; 5. Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention; 6. 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; 7. Pregnant or breastfeeding women; 8. Patients with benign or malignant tumors or autoimmune diseases; 9. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xi'an International Medical Center Hospital
RECRUITINGXi'an, Shaanxi, 710032, China
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Xijing Hospital
RECRUITINGXi'an, Shaanxi, 710032, China
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Other studies related to the condition(s) this trial covers.
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