Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder

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.

NCT Number	NCT07323407
Lead Sponsor	Xijing Hospital of Digestive Diseases
Conditions	Functional Constipation (FC), Somatic Symptom Disorder (DSM-5), Refractory Constipation
Enrollment	60 participants
Start Date	2025-08-20
Primary Completion	2026-07-30 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-09