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A multicenter clinical study on deep brain stimulation of bilateral anterior nucleus of thalamus for patients with refractory epilepsy

A multicenter clinical study on deep brain stimulation of bilateral anterior nucleus of thalamus for patients with refractory epilepsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015813
Enrollment
Unknown
Registered
2018-04-22
Start date
2018-04-22
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Epilepsy

Interventions

Case series:deep brain stimulation

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Be between 18 and 60 years of age at the time of surgery; 2. Failure of pharmacological therapies (pharmacoresistant epilepsy) (persistent seizures despite at least two anti-epileptic treatments used at the optimal dose for at least 2 years); 3. Bilateral or multifocal epilepsy; 4. Patients with refractory epilepsy who have difficulty in resection or who refuse to undergo resection surgery; 5. persistent partial-onset seizures after resection surgery; 6. Patient or legal guardian understands study procedures and has voluntarily signed an informed consent; 7. Patient who is willing to abide by relevant regulations and complete study evaluations before the deadline.

Exclusion criteria

Exclusion criteria: 1. Patient with brain tumors or other degenerative disorders of the central nervous system; 2. Patient with mental disorders and the relevant examination cannot be acquired; 3. Patient with structural changes in the thalamus; 4. Patient with severe cognitive impairment, Intelligence quotient less than 55; 5. Patient with generalized or special types of hereditary epilepsy; 6. Woman of childbearing potential without effective contraception or pregnant or lactating or patient who have a high risk of bleeding; 7. Patient with other serious physical diseases or severe abnormalities of liver and kidney function, which affect the follow-up; 8. There are objective factors that cannot complete the follow-up (economic factors, traffic factors, etc.); 9. Abnormal laboratory tests during the screening period, or other laboratory abnormalities that are clinically significant; 10. Patient who is unwilling to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Change in Seizure Rate;quality of life in epilepsy;Seizure Severity;

Secondary

MeasureTime frame
stimulation parameters;Electrodes resistance;

Countries

China

Contacts

Public ContactTao Yu

Xuanwu Hospital, Capital Medical University

yutaoly@sina.com+86 010 83199243

Outcome results

None listed

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