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Physician-Led Clinical Trials Evaluating the Efficacy and Safety of Hydrogel Electrodes.

Physician-Led Clinical Trials Evaluating the Efficacy and Safety of Hydrogel Electrodes.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2022220026
Enrollment
3
Registered
2022-10-20
Start date
2023-02-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Drug-resistant epilepsy

Interventions

(1)During normal brain stimulator implantation (including intracranial electrode implantation), anesthesia and medical devices are set in the same manner, and the implantation site of the electrode is

Sponsors

Osawa Shinichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Men and women aged 3 years or older at the time of informed consent. (2) Patients who gave written consent to participate in the study by their free will. However, if it is difficult to sign the informed consent form by the patient itself due to the effects of neurological symptoms, etc., even if the explanatory content is understood and oral consent can be obtained, the patient shall confirm that verbal consent has been obtained from the patient for participation in the clinical trial, and obtain written informed consent by either of the following methods. Substitute authorship by proxy consenter Authorship by the author after describing the relationship with the patient and the history of writing under the presence and signature of a fair attendant by a person who is not equivalent to a representative. When it is difficult to understand the patient in the same explanatory document as the adult due to age < 18 years or the effects of the disease, informed consent will be obtained from the patient and informed consent will be obtained from the patient using the pediatric information document (Acent document) as appropriate. (3) Patients with drug-resistant epilepsy and an indication for epilepsy focal resection. (4) Patients requiring long-term continuous intracranial electroencephalography as a preoperative test for epilepsy focal resection.

Exclusion criteria

Exclusion criteria: (1) Patients with severe bleeding diathesis, immunodeficiency, cardiovascular disorders, respiratory dysfunction, hematologic disorders, etc. (2) Individuals who are unable to undergo MRI examination because of implants that are metallic, metallic foreign bodies, defibrillators, or pacemakers that are not compliant with MRI. (3) Patients who are receiving anticoagulation and antiplatelet therapy and are unable to withdraw from the study. (4) Patients who are pregnant or of childbearing potential. (5) Patients participating in medical device clinical trials. (6) Other patients who are judged difficult to participate in the study by the principal investigator or a sub-investigator.

Design outcomes

Primary

MeasureTime frame
(1) Feeling of using the practitioner (2) Discrimination of Epileptic Seizures on Electroencephalography Measurements

Contacts

Public ContactShinichiro Osawa

Tohoku University Hospital

osawa@nsg.med.tohoku.ac.jp+81-22-717-7752

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026