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Clinical trial protocols to evaluate the safety and efficacy of single-use intracranial brain electrodes radiofrequency thermocoagulation in the treatment of epilepsy

Clinical trial protocols to evaluate the safety and efficacy of single-use intracranial brain electrodes radiofrequency thermocoagulation in the treatment of epilepsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068975
Enrollment
Unknown
Registered
2023-03-02
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

None listed

Interventions

Experimental group:Radiofrequency thermocoagulation using intracranial brain electrodes for epilepsy treatment at once

Sponsors

Beijing Tiantan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, aged 8-60 years; 2. Previously diagnosed as drug-resistant epilepsy; 3. Patients who have no less than one seizure per month; 4. Patients who plan to undergo stereotactic electroencephalogram monitoring and surgical treatment; 5. Those who have not participated in other clinical trials within three months; 6. The patient or his/her guardian can understand the purpose of the experiment, comply with the experiment protocol, participate voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe coagulation dysfunction; 2. Allergic to electrode materials; 3. Patients with pacemakers or other active implants; 4. Patients with contraindications of neurosurgery and serious cardiovascular and cerebrovascular diseases; 5. Systemic diseases that seriously affect health, such as severe abnormal liver and kidney function; 6. Patients who are pregnant or have pregnancy intention in recent half a year, or lactating patients; 7. Patients deemed unsuitable for clinical trials by the investigator.

Design outcomes

Primary

MeasureTime frame
The frequency of seizures at 84 days after surgery was compared with baseline to verify that the effective rate of thermocoagulation treatment for epilepsy met the preset target value;Verify that the diameter of the short shaft of the thermal coagulation damage range meets the preset target value;

Secondary

MeasureTime frame
Success rate of electrode implantation;Immediate success rate of thermocoagulation;Electroencephalogram changes before and after thermocoagulation;The performance of the device was evaluated by the investigators;

Countries

China

Contacts

Public ContactZhang Kai

Beijing Tiantan Hospital Affiliated to Capital Medical University

zhangkai62035@sina.com+86 135 0119 6619

Outcome results

None listed

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