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NCT06141668 · ClinicalTrials.gov registry record · NA

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

A NA study of Refractory Epilepsy, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT06141668: Recruiting NA study of Refractory Epilepsy, sponsored by Massachusetts General Hospital.

NCT06141668 is a NA study of Refractory Epilepsy that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 61-participant average among 4 other Refractory Epilepsy trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06141668, a NA study of Refractory Epilepsy, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Spike ripple rate \~ 1 + condition + (1\|subject) This is a within-subject repeated-measures study design analyzed using a generalized linear mixed-effects model. Effect size for each arm (+/- 95% confidence interval) reported below. Treatment response was assessed using the change in spike ripple rate (SR rate) relative to each subject's baseline. For each subject, the treatment response at each stimulation frequency (1 Hz, 20 Hz, 40 Hz, 140 Hz, and 200 Hz) was calculated by subtracting the s

Conditions Studied

Interventions

  • OTHER Neurostimulation

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-06-13
Est. Completion 2026-11-30
Phase NA
Massachusetts General Hospital

2,032 total trials

What NCT06141668 shows while recruiting

NCT06141668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 61-participant average among 4 other Refractory Epilepsy trials with a reported enrollment target (51% lower).

The record links to 1 condition, with Refractory Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Neurostimulation is the first listed.

NCT06141668 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06141668 about?

NCT06141668 is a clinical study titled "Optimal Stimulation Parameters to Disrupt Epileptiform Activity". 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 parame...

What is the current status of trial NCT06141668?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-06-13. Estimated completion is 2026-11-30.

What conditions does trial NCT06141668 study?

This clinical trial studies the following conditions: Refractory Epilepsy.

What interventions are being tested in trial NCT06141668?

The interventions under investigation include: Neurostimulation (OTHER).

Who is sponsoring clinical trial NCT06141668?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06141668 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06141668, the US trial registry maintained by the National Library of Medicine. NCT06141668 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.