NCT06141668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

November 15, 2023

Last Update Submit

April 26, 2026

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Spike ripple rate

    Spike ripple rate (count per minute)

    1-3 hours

Secondary Outcomes (1)

  • Spike rate

    1-3 hours

Study Arms (1)

No Stimulation versus stimulation

EXPERIMENTAL

No Stimulation versus stimulation at 1 Hz, 40 Hz, 140 Hz, 200 Hz, and 333 Hz

Other: Neurostimulation

Interventions

NeurostimulationOTHER

Electrical stimulation

No Stimulation versus stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Baseline spike ripple rate \< 0.5/min.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Catherine Chu, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Neurology

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

June 13, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)