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Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder

NCT07323407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-07-30
Completion
2026-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07323407 on ClinicalTrials.gov