Refractory EpilepsyEarly Phase 1NCT05493722
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
A Early Phase 1 study testing Physician-Selected Settings Stimulation, Optimized Settings Stimulation and DBS Setting Optimization in people with Refractory Epilepsy and Deep Brain Stimulation, run by University of Minnesota at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy, Deep Brain Stimulation
- What is being tested?
- Physician-Selected Settings Stimulation, Optimized Settings Stimulation and DBS Setting Optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 15 Jan 2030
- Phase
- Early Phase 1
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
- medically refractory epilepsy
- already have a deep brain stimulator in place
Who cannot join
- severe dementia at investigator discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Anusha Duggirala, 612-624-3672, duggi008@umn.edu
About this study
Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.
- Conditions
- Refractory Epilepsy, Deep Brain Stimulation
- Being tested
- Physician-Selected Settings Stimulation, Optimized Settings Stimulation, DBS Setting Optimization
- Keywords
- Refractory Epilepsy, 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.
Physician-Selected Settings StimulationOther
Participants will receive deep brain stimulation using physician-selected settings
Optimized Settings StimulationOther
Participants will receive deep brain stimulation using optimized settings determined through setting optimization.
DBS Setting OptimizationOther
Participants with electrodes in a thalamic location other than the anterior nucleus of the thalamus will undergo deep brain stimulation setting optimization but will not be randomized to one of the three stimulation-sequence groups.
| Study group | Role | What they receive |
|---|---|---|
| PS, OS, OS Stimulation Sequence | Experimental | Participants with electrodes in the anterior nucleus of the thalamus will receive physician-selected settings stimulation for 4 months, followed by optimized settings stimulation for 8 months. Receives: Other: Physician-Selected Settings Stimulation; Other: Optimized Settings Stimulation |
| OS, PS, OS Stimulation Sequence | Experimental | Participants with electrodes in the anterior nucleus of the thalamus will receive optimized settings stimulation for 4 months, followed by physician-selected settings stimulation for 4 months, then optimized settings stimulation for 4 months. Receives: Other: Physician-Selected Settings Stimulation; Other: Optimized Settings Stimulation |
| OS, OS, PS Stimulation Sequence | Experimental | Participants with electrodes in the anterior nucleus of the thalamus will receive optimized settings stimulation for 8 months, followed by physician-selected settings stimulation for 4 months. Receives: Other: Physician-Selected Settings Stimulation; Other: Optimized Settings Stimulation |
| Non-Anterior Thalamic Electrode Location | Experimental | Participants with electrodes in a thalamic location other than the anterior nucleus of the thalamus will undergo setting optimization but will not be randomized to the three stimulation-order groups. Receives: Other: DBS Setting Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in broadband power with different settings
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in broadband power.
Measured: One year from baseline
Difference in frequency band-specific low-frequency power (LFP) with different settings
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in frequency band-specific LFP.
Measured: One year from baseline
Secondary outcomes (3)
Identify all seizures
Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.
Measured: one year from baseline
Scores on Montreal Cognitive Assessment, MoCA
This is a brief cognitive assessment used to look at side effects of stimulation settings
Measured: one year from baseline
Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)
This is a brief cognitive assessment used to look at side effects of stimulation settings
Measured: One year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jul 2021
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2030 (estimated)
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.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants with electrodes in the anterior nucleus of the thalamus will be randomly assigned to one of three stimulation-order groups at the baseline visit, with optimized settings (OS) stimulation occurring for a total of 8 months and physician-selected settings (PS) stimulation occurring for a total of 4 months. The three possible stimulation groups are: 1) PS, OS, OS; 2) OS, PS, OS; and 3) OS, OS, PS. Participants with electrodes in another thalamic location other than the anterior nucleus will undergo setting optimization but will not be randomized to one of the three stimulation-order groups.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert McGovern, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493722
- Sponsor's protocol ID
- NEUROSURG-2021-29636
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No