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Clinical trials to evaluate the safety and efficacy of implantable neurostimulation needle electrodes for monitoring intracranial EEG in patients with drug-refractory epilepsy

Clinical trials to evaluate the safety and efficacy of implantable neurostimulation needle electrodes for monitoring intracranial EEG in patients with drug-refractory epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088451
Enrollment
Unknown
Registered
2024-08-19
Start date
2024-08-26
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

drug-refractory epilepsy

Interventions

Treatment group:Implantable neurostimulation needle electrodes are used to monitor intracranial EEG in patients with drug-refractory epilepsy

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Male or female = age 6 years old and = 60 years old; (2) Previous diagnosis of drug-refractory epilepsy; (3) Those who have seizures at least once a month; (4) Those who intend to undergo stereotactic EEG monitoring; (5) Those who have not participated in other clinical trials within three months; (6) The subjects or their guardians can understand the purpose of the trial, comply well with the trial protocol, voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with severe coagulation disorders; (2) Those who are allergic to electrode materials; (3) Those who have a pacemaker or other active implant in the body; (4) Patients with contraindications to neurosurgery and severe cardiovascular and cerebrovascular diseases; (5) Systemic diseases that seriously affect health, such as severe abnormalities in liver and kidney function; (6) Pregnant women or women who intend to become pregnant in the past six months, or lactating women; (7) Those who are considered unsuitable by the investigator to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
success rate of intracranial EEG signal recording;

Secondary

MeasureTime frame
The investigator's evaluation of the performance of the device;

Countries

China

Contacts

Public ContactZhang Hua

The First Affiliated Hospital of Xi'an Jiaotong University

zhanghua@xjtu.edu.cn+86 189 0922 5508

Outcome results

None listed

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