- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06141668
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
November 15, 2023 updated by: Catherine Chu, MD, Massachusetts General Hospital
Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Chu, MD
- Phone Number: 617726-6540
- Email: cjchu@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Catherine Chu
- Phone Number: 617-726-6540
- Email: cjchu@mgh.harvard.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria: Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation -
Exclusion Criteria: Baseline spike ripple rate < 0.5/min.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spike ripple rate
Time Frame: 1-3 hours
|
1-3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spike rate
Time Frame: 1-3 hours
|
1-3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine Chu, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2023
Primary Completion (Estimated)
November 30, 2025
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
November 15, 2023
First Submitted That Met QC Criteria
November 15, 2023
First Posted (Estimated)
November 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P002398
- R01NS119483 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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