Refractory EpilepsyNCT06141668
Optimal Stimulation Parameters to Disrupt Epileptiform Activity
A study testing Neurostimulation in people with Refractory Epilepsy, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Neurostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation.
- Consented for stimulation experiment.
Who cannot join
- Baseline spike ripple rate < 0.5/min.
- Did not complete 3 hours of stimulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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 compared the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.
- Conditions
- Refractory Epilepsy
- Being tested
- Neurostimulation
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationOther
Electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Within subject multi-frequency stimulation | Experimental | Baseline/no stimulation:
1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation Receives: Other: Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spike Ripple Rate (Events Per Minute)
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 subject's baseline SR rate from the SR rate measured after stimulation at that frequency. Positive values indicate an increase in SR Rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
Measured: 3 hours
Secondary outcomes (1)
Spike Rate (Events Per Minute)
Spike 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 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 subject's baseline spike rate from the spike rate measured after stimulation at that frequency. Positive values indicate an increase in spike rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start13 Jun 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Catherine Chu, MD, Massachusetts General Hospital
- Investigators
- Catherine Chu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141668
- Sponsor's protocol ID
- 2020P002398
- Other IDs
- R01NS119483
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2023
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Stimulation Parameters for Spike-ripple Disruption in Patients Undergoing Invasive Monitoring
- ClinicalTrials.gov ID
- NCT06141668
- Acronym / sponsor ID
- 2020P002398
- Conditions
- Refractory Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 compared the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Within subject multi-frequency stimulation | Experimental | Other: NeurostimulationBaseline/no stimulation: 1 Hz stimulation 20 Hz stimulation 40 Hz stimulation 140 Hz stimulation 200 Hz stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation.
- Consented for stimulation experiment.
Key exclusion criteria (2 listed)
- Baseline spike ripple rate < 0.5/min.
- Did not complete 3 hours of stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurostimulationElectrical stimulation | Other | Within subject multi-frequency stimulation |
Primary outcome
Spike Ripple Rate (Events Per Minute)
Time frame: 3 hours
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 subject's baseline SR rate from the SR rate measured after stimulation at that frequency. Positive values indicate an increase in SR Rate relative to baseline, whereas negative values indicate a decrease relative to baseline.
1 secondary outcome
Spike Rate (Events Per Minute)
Time frame: 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Chu, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation in people with Refractory Epilepsy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spike Ripple Rate (Events Per Minute) (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.