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Effect of external trigeminal nerve stimulation for drug-resistant epilepsy

Effect of external trigeminal nerve stimulation for drug-resistant epilepsy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062522
Enrollment
Unknown
Registered
2022-08-10
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

drug-resistant epilepsy

Interventions

Experimental group:Basic medicine + eTNS
control group:Basic drugs + Sham stimulation

Sponsors

Xi'an Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to 18 years old and less than or equal to 80 years old; 2. Patients with drug-resistant epilepsy; 3. There was no change in antiseizure medications (ASMs) dose for at least 30 days prior to study participation 4. Patients sign informed consent forms 5. Be able and willing to cooperate to complete the record.

Exclusion criteria

Exclusion criteria: 1. Any serious mental disorder (such as schizophrenia or delusional disorder); 2. Brain injury with loss of consciousness or suicidality; 3. Pacemaker implants or other metal implant devices; 4. Concomitant progressive central nervous system disease or severe heart, liver, kidney, and blood disorders; 5. Presence of cardiovascular disease (such as significant arrhythmias, heart failure or ischemic heart disease); 6. There is a history of non-epileptic seizures; 7. Current or former participants in other percutaneous electrical stimulation therapy for less than 3 months; 8. Pregnancy and lactation or inadequate contraception; 9. Have a history of facial pain or trigeminal nerve pain; 10. MRI contraindications: metal implantation in the body, claustrophobia, etc; 11. Smoking addicts, alcoholics; 12. The patient or family member cannot fully comply with the treatment plan; 13. Participants in other clinical trials; 14. Refusal to sign informed consent.

Design outcomes

Secondary

MeasureTime frame
Changes in anxiety and depressive state scores;Changes in the degree of seizures;Changes in sleep quality scores;Changes in cognitive function scores;Quality of life score changes;Assessment of brain function and autonomic nervous function;

Primary

MeasureTime frame
Treatment response (50% reduction in seizure frequency was defined as effective);

Countries

China

Contacts

Public ContactZhengli Di
zhenglidi@126.com+86 13991161359

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026