Refractory EpilepsyNCT04753983
A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
A study testing Functional magnetic resonance imaging (fMRI) in people with Refractory Epilepsy, run by Mayo Clinic.
Trial summary
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Functional magnetic resonance imaging (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.
Who cannot join
- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
About this study
Official title: fMRI of Active DBS Stimulation in Epilepsy
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).
Read the detailed description
Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.
- Conditions
- Refractory Epilepsy
- Being tested
- Functional magnetic resonance imaging (fMRI)
- Keywords
- Deep Brain Stimulation
- 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.
Functional magnetic resonance imaging (fMRI)Diagnostic test
Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity
| Study group | Role | What they receive |
|---|---|---|
| Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS) | Experimental | Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the "on" and "off" state with high- and low frequency settings to measure the brain activation changes induced by the DBS. Receives: Diagnostic Test: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document brain activation networks with ANT stimulation
Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.
Measured: Results would be available immediately following processing of the imaging data after each scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startSep 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: No longer have funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven A. Messina, Mayo Clinic
- Investigators
- Steven A Messina, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753983
- Sponsor's protocol ID
- 20-006464
- Status last verified
- Oct 2022
- First submitted
- 9 Feb 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI of Active DBS Stimulation in Epilepsy
- ClinicalTrials.gov ID
- NCT04753983
- Acronym / sponsor ID
- 20-006464
- Conditions
- Refractory Epilepsy
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer have funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).
Detailed description
Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS) | Experimental | Diagnostic Test: Functional magnetic resonance imaging (fMRI)Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the "on" and "off" state with high- and low frequency settings to measure the brain activation changes induced by the DBS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy.
Key exclusion criteria (1 listed)
- Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).
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 |
|---|---|---|
| Functional magnetic resonance imaging (fMRI)Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity | Diagnostic test | Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS) |
Primary outcome
Document brain activation networks with ANT stimulation
Time frame: Results would be available immediately following processing of the imaging data after each scan
Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Steven A Messina, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging (fMRI) in people with Refractory Epilepsy, run by Mayo Clinic.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Document brain activation networks with ANT stimulation (time frame: Results would be available immediately following processing of the imaging data after each scan). 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 1 Nov 2022.