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Multicenter, randomized cross-control study to evaluate the efficacy of low-frequency and high-frequency deep brain stimulation in the treatment of drug-refractory partial epilepsy

Multicenter, randomized cross-control study to evaluate the efficacy of low-frequency and high-frequency deep brain stimulation in the treatment of drug-refractory partial epilepsy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023842
Enrollment
Unknown
Registered
2019-06-14
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

partial epilepsy

Interventions

1:LFS first, then HFS
2:HFS first, then LFS

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years; 2) Regular use of two or more antiepileptic drugs to achieve the optimal drug dosage, but epilepsy still does not alleviate, the number of seizures is still 2 times/month or more; 3) Patients with partial seizures of epilepsy, including secondary tonic-clonic epilepsy (sGTCS); 4) After strict preoperative evaluation, those who are still unable to undergo excisional surgery or who have poor expectations of excisional surgery are still unable to do so; 5) The patient or his family members can fully understand the treatment and sign the informed consent; 6) The patients have good compliance and can cooperate with the requirements of follow-up after operation.

Exclusion criteria

Exclusion criteria: 1) Those who take antiepileptic drugs irregularly to reach the best dosage of drug treatment; 2) IQ < 70; 3) There are mental, cognitive and psychological disorders, unable to sign informed consent or cooperate with surgery and follow-up; 4) There are contraindications of neurosurgery, such as cerebral infarction, hydrocephalus, brain atrophy, ventricular enlargement, sequelae of cerebrovascular disease, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases; 5) There are other concomitant diseases, such as pacemaker, defibrillator, cochlear implant, etc.; 6) There are concomitant diseases that seriously affect health, such as tumors, severe abnormalities of liver function and kidney function (indicators exceeding three times the normal value).

Design outcomes

Primary

MeasureTime frame
seizure frequency;

Secondary

MeasureTime frame
Severity of epilepsy;quality of life;

Countries

China

Contacts

Public ContactZhang Kai

Beijing Tiantan Hospital, Capital Medical University

zhangkai62035@163.com+86 13501196619

Outcome results

None listed

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