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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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).
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.
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
RECRUITINGXijing Hospital
Xi'an, Shaanxi, China
RECRUITINGThe 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 week
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 period
Change from baseline in weekly frequency of spontaneous bowel movements (SBM)
Time frame: Baseline and each week during Weeks 1-4
Change from baseline in weekly frequency of complete spontaneous bowel movements (CSBM)
Time frame: Baseline and each week during Weeks 1-4
Change from baseline in stool consistency (Bristol Stool Form Scale) for weekly SBMs
Time frame: Baseline and Weeks 3-4
Change from baseline in straining score for weekly SBMs (4-point scale: 0=no difficulty, 1=mild, 2=moderate, 3=severe)
Time frame: Baseline and Weeks 3-4
Change from baseline in abdominal bloating severity (5-point scale: 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe)
Time frame: Baseline and Weeks 3-4
Change from baseline in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline and Week 4
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline and Week 4
Change from baseline in Patient Health Questionnaire-15 (PHQ-15) somatic symptom score
Time frame: Baseline and Week 4
Change from baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL)
Time frame: Baseline and Week 4
Proportion of participants using polyethylene glycol (PEG) as rescue medication
Time frame: During the 4-week treatment period
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