Safety Evaluation of Hippocampal Stimulation Targeting Sharp Wave Ripple

JRCT ID: jRCTs052230082

Registered date:01/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: epilepsy
• Date of first enrollment: 01/08/2023
• Target sample size: 4
• Study type: Interventional

Intervention(s)

(1) Synchronous stimulation
After the implantation of intracranial electrodes, SWR is detected from the intracranial electrodes implanted around the hippocampus, and electrical stimulation is performed under the stimulation conditions of 70-180 Hz for 100 ms according to the SWR. The maximum stimulation intensity is 1-15mA according to Shannon's criteria. After discharge should be monitored during stimulation to avoid inducing epilepsy.
(2) Random stimulation
Rondom stimulation is performed under conditions with a random delay of 400 ms to 1000 ms for the detected SWR.

Outcome(s)

• Primary Outcome: Adverse events caused by electrical stimulation around the hippocampus after intracranial electrode implantation (includes only epileptic seizures with after discharge immediately after stimulation)

Secondary Outcome

(1) Correct response rate and reaction time of Sternberg's working memory task under electrical stimulation of electrodes around the hippocampus after intracranial electrode implantation
(2) Frequency of SWR around the hippocampus for each task

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Primary Registration
(1) Patients who have had electrodes implanted around the hippocampus during preoperative examinations for epilepsy.
(2) Patients who are between 18 and 80 years of age at the time of consent.
(3) Patients who have given written consent to participate in this study from themselves or their representative.
(4) Those who score 22 or higher on the MMSE.
Secondary enrollment
(5) Those with a correct response rate of 60% or higher on the 60 Sternberg working memory tasks with a load of 3 or higher.

Exclude criteria

Primary Registration
(1) Patients who are considered incapable of performing the task due to severe higher-order functional disabilities.
(2) Patients who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects for other reasons.
Secondary registration
Not particularly.

Related Information

• Primary Sponsor: Yanagisawa Takufumi Takufumi