NCT07323407

Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Functional Constipation (FC)
• Somatic Symptom Disorder (DSM-5)
• Refractory Constipation

Interventions

Type	Name	Description
DEVICE	Transcranial Alternating Current Stimulation	Electrode 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).
DEVICE	Placebo	Electrode 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.

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-07-30
• Completion: 2026-12-01
• First posted: 2026-01-07
• Last updated: 2026-01-09

Locations

2 sites across 1 country: China