Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital of Digestive Diseases
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Alternating Current Stimulation
DeviceElectrode placement: Referenced to the forehead (Fpz) and bilateral mastoid regions, covering the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Alternating current, 15 mA intensity, 77.5 Hz frequency. Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks).
Placebo
DeviceElectrode placement: Same as active-referenced to the forehead (Fpz) and bilateral mastoid regions, to mimic coverage of the prefrontal cortex and related brain-gut axis pathways. Stimulation parameters: Sham stimulation; the device is programmed to deliver a brief ramp-up and ramp-down at session start (e.g., ≤30 seconds total) to reproduce initial skin sensations, followed by no sustained current (0 mA effective intensity; no therapeutic stimulation). Dosing schedule: Once daily, 30-40 minutes per session, for 4 consecutive weeks (20 sessions total; Monday-Friday with weekend breaks). Blinding procedures: Device display, sounds, and electrode preparation identical to the active arm; session duration and operator interactions matched to maintain participant and assessor blinding.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: tACSExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weekSecondary outcomes
1
Proportion of participants achieving an increase of ≥1 CSBM from baseline in at least 2 weeks during follow-up
Time frame
Weeks 1-4 follow-up; assessed over the 4-week period2
Change from baseline in weekly frequency of spontaneous bowel movements (SBM)
Time frame
Baseline and each week during Weeks 1-43
Change from baseline in weekly frequency of complete spontaneous bowel movements (CSBM)
Time frame
Baseline and each week during Weeks 1-44
Change from baseline in stool consistency (Bristol Stool Form Scale) for weekly SBMs
Time frame
Baseline and Weeks 3-4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov