Study of Brain Stimulation tACS for Adults With Hard-to-Treat Constipation and Somatic Symptom Disorder

What This Trial Is About

Researchers are evaluating the safety and effectiveness of transcranial alternating current stimulation tACS in adults who have refractory functional constipation along with somatic symptom disorder. This condition involves ongoing bowel problems despite usual treatments, frequent use of laxatives, and disrupted brain-gut communication contributing to persistent symptoms. The study aims to assess improvements in bowel function, symptom severity, quality of life, and the safety and tolerability of tACS compared to a placebo. Participants are randomly assigned to receive either active tACS or placebo stimulation. The tACS involves placing electrodes on the forehead and mastoid areas to target brain regions involved in bowel control, delivering alternating current at 15 mA and 77.5 Hz for 30 to 40 minutes daily over 4 weeks 20 sessions. The placebo group receives sham stimulation mimicking the procedure without sustained current. The study is double-blind with identical procedures for both groups. During the study, participants will track their bowel movements and complete questionnaires on constipation symptoms and quality of life. Researchers will monitor changes in bowel movement frequency, stool consistency, abdominal bloating, and psychological symptoms throughout the 4-week treatment and follow-up periods. Adverse events and patient tolerability will also be recorded. The main outcome is the proportion of patients who achieve an increase of at least one complete spontaneous bowel movement per week during treatment.

Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder