NCT07392645

Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms

Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Lishu Gao · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) in treating Generalized Anxiety Disorder (GAD). Participants will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants will continue their routine medication (Paroxetine). The primary goal is to observe the reduction in anxiety symptoms using the Hamilton Anxiety Scale (HAMA). Additionally, the study will use functional MRI (fMRI) and Magnetic Resonance Spectroscopy (MRS) to explore the brain mechanisms through which EA helps alleviate anxiety.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
PROCEDURE	Electroacupuncture (EA)	Electroacupuncture (EA) is performed at acupoints including GV20 (Baihui), EX-HN1 (Sishencong), GV29 (Shenting), EX-HN16 (Anmian, bilateral), HT7 (Shenmen, bilateral), PC6 (Neiguan, bilateral), CV6 (Qihai), CV4 (Guanyuan), ST36 (Zusanli, bilateral), SP6 (Sanyinjiao, bilateral), and LR3 (Taichong, bilateral). Sterile disposable needles (φ0.18×25mm or φ0.25×40mm) are used. Electric stimulation (continuous wave, 100Hz) is applied to specific point pairs (e.g., left Sishencong + anterior Sishencong) for 30 minutes. The current intensity is adjusted to the patient's maximum tolerance. Treatment is administered 3 times per week for 4 weeks (12 sessions total).
PROCEDURE	Sham Electroacupuncture (SEA)	Sham electroacupuncture (SEA) is performed by inserting needles into non-acupoints located 5-10 mm away from the real points used in the EA group. Shallow needling (depth of 1-2 mm) is applied. A sham EA device with a disconnected electrode lead is used; although the screen displays parameters identical to the EA group, there is no actual current output. The duration, frequency, and total number of sessions are identical to the EA group (3 times/week for 4 weeks).
DRUG	Routine Medication	All groups receive Paroxetine Hydrochloride Tablets (20 mg/tablet). The initial dose is 20 mg once daily, taken orally. The daily dose may be increased in increments of 10 mg based on the patient's condition, with a minimum interval of 1 week between adjustments. The maximum daily dose is 50 mg.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-10-31
• Completion: 2027-12-31
• First posted: 2026-02-06
• Last updated: 2026-02-06