Optimal Stimulation Parameters to Disrupt Epileptiform Ac... | NCT06141668

Studies
Optimal Stimulation Parameters to Disrupt Epileptiform Activity

NCT06141668

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Apr 30, 2026Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Refractory Epilepsy

Interventions

Neurostimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01NS119483	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2023Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2026

Last Update Posted Date

Apr 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Catherine Chu, MD, Associate Professor Neurology, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Boston University	OTHER
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Stimulation versus stimulation	Experimental	No Stimulation versus stimulation at 1 Hz, 40 Hz, 140 Hz, 200 Hz, and 333 Hz	Other: Neurostimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurostimulation	Other	Electrical stimulation	No Stimulation versus stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spike ripple rate	Spike ripple rate (count per minute)	1-3 hours

Secondary Outcomes

Measure	Description	Time Frame
Spike rate	Spike rate (count per minute)	1-3 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation

Exclusion Criteria:

- Baseline spike ripple rate < 0.5/min.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine Chu, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 28, 2026

Condition Browse Module

MeSH Terms

ID	Term
D000069279	Drug Resistant Epilepsy

Ancestor Terms

ID	Term
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided