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A clinical study on the safety and efficacy of closed-loop stimulation algorithms in patients with refractory epilepsy

A clinical study on the safety and efficacy of closed-loop stimulation algorithms in patients with refractory epilepsy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075719
Enrollment
Unknown
Registered
2023-09-13
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

epilepsy

Interventions

Experimental group:Individualized closed-loop stimulation

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) 2-18 years old, regardless of gender; (2) patients diagnosed with medically intractable epilepsy and need to undergo surgical treatment; (3) The stereotactic intracranial electrode has been implanted in patients, patients have been monitored for 3-5 times or more epileptic seizures, the focal epilepsy has been diagnosed, and functional mapping was completed; (4) Patients or their family members can fully understand the treatment, have good compliance, can cooperate with researchers to complete the whole clinical study, and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with epilepsy combined with epileptic pseudoseizures; (2) Patients complicated with severe mental or nervous system diseases; (3) Coagulation dysfunction and inability to stop anticoagulant drugs; (4) Neurosurgical contraindications; (5) Unable to comply with the protocol to complete the study or/and follow-up; (6) Patients who are participating in other clinical trials and have not yet been out of group; (7) Other conditions considered inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
adverse event rate;epileptic seizure detection rate;

Secondary

MeasureTime frame
the percentage reduction of timing of seizure;Fall-out ratio;

Countries

China

Contacts

Public ContactLiang Shuli

Beijing Children's Hospital, Capital Medical University

301_1sjwk@sina.com+86 134 3939 0206

Outcome results

None listed

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