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NCT06141668 Clinical Trial

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Refractory Epilepsy Clinical Trial

Official title:
Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06141668
Other study ID # 2020P002398
Secondary ID R01NS119483
Status Recruiting
Phase N/A
First received
Last updated
Start date June 13, 2023
Est. completion date November 30, 2026

Study information
Verified date November 2023
Source Massachusetts General Hospital
Contact Catherine Chu, MD
Phone 617726-6540
Email cjchu@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 30, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation - Exclusion Criteria: Baseline spike ripple rate < 0.5/min. -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Neurostimulation
Electrical stimulation

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Boston University, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spike ripple rate 1-3 hours
Secondary Spike rate 1-3 hours
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