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Clinical Efficacy Study of Biofeedback Combined with Microcurrent Stimulation for the Treatment of Anxiety Disorders

Clinical Efficacy Study of Biofeedback Combined with Microcurrent Stimulation for the Treatment of Anxiety Disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119214
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety disorder

Interventions

Experimental Group 1:Biofeedback combined with microcurrent stimulation
Experimental Group 2:Biofeedback combined with microcurrent stimulation
Experimental Group 3:Pure microcurrent stimulation intervention
Experimental Group 4:Pure microcurrent stimulation intervention
Control group:Sham biofeedback therapy combined with sham microcurrent stimulation intervention

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with an anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), or anxiety with depression where anxiety is the primary diagnosis; 2. Hamilton Anxiety Scale (HAMA) score >=22; 3. Hamilton Depression Rating Scale (HAMD-17) score <=17; 4. Age range 18-65 years; 5. First-time patients who have not used medication or have had poor response to medication; 6. Not participating in other physical therapies outside of this experiment; 7. Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects meet the DSM-V criteria, excluding anxiety disorders as the primary diagnosis (i.e., schizophrenia, depression, mood disorders, psychosis, anorexia nervosa); 2. History of skin lesions, eczema, or other skin conditions affecting the skin behind the ears (e.g., psoriasis); 3. History of suicide attempts within the past year, or currently at high risk of suicide, or patients with a score of =2 on item 3 of the Hamilton Depression Rating Scale (HAMD-17); 4. Previously diagnosed with HIV infection or AIDS; 5. History of stroke or severe head injury (defined as head injury requiring craniotomy or intubation); 6. Presence of permanently implanted battery-powered medical devices or stimulators (e.g., pacemaker, implantable defibrillator, deep brain stimulator, vagus nerve stimulator, etc.); 7. Women who are pregnant, breastfeeding, or planning to become pregnant; 8. History of epilepsy; 9. History of migraine with aura; 10. History of head injury requiring intensive care or neurosurgery; 11. History of cognitive impairment; 12. History of malignant tumors in the past year or presence of malignant tumors (excluding basal cell carcinoma, squamous cell carcinoma, and carcinoma in situ) diagnosed with myelofibrosis or myelodysplastic syndrome; 13. Concurrent use of drugs that interact with or are explicitly contraindicated for the study device; 14. Use of drugs that may induce seizures within the past month.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Rating Scale (HAMA);

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Hamilton Depression Rating Scale;

Countries

China

Contacts

Public ContactMengqian li

The first affiliated hostipal of nanchang university

limengqian@126.com+86 791 88692280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026