Refractory EpilepsyNCT03331939
Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition in Patients With Refractory Epilepsy
A study testing no stimulation, beta (25-30 Hz) and Theta (5 Hz) in people with Refractory Epilepsy, run by University of California, Davis.
Trial summary
The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. 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?
- no stimulation, beta (25-30 Hz) and Theta (5 Hz)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2017to 31 Oct 2017
- 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
- Diagnosis of Refractory Epilepsy
- Previously implanted vagal nerve stimulator
- Willingness and ability to undergo temporary changes to their VNS device settings
Who cannot join
- <18 years of age
- Adults unable to consent
- Pregnant women
- Prisoners
- >20 on the Beck Depression Inventory (BDI)
- <24 on the Montreal Cognitive Assessment (MOCA)
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- Adults with diagnosis of developmental delay, intellectual disability, or traumatic brain injury (TBI).
- Adults with reported history of learning disability.
- Adults unable to use a computer with their dominant hand.
- Status Epilepticus within the past 6 months
About this study
Official title: Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
The purpose of this investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.
- Conditions
- Refractory Epilepsy
- Being tested
- no stimulation, beta (25-30 Hz), Theta (5 Hz)
- 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.
no stimulationOther
Vagal nerve stimulator will be set to no stimulation
beta (25-30 Hz)Other
Vagal nerve stimulator will be set to beta (25-30 Hz)
Theta (5 Hz)Other
Vagal nerve stimulator will be set to beta (5 Hz)
| Study group | Role | What they receive |
|---|---|---|
| No stimulation | Experimental | All patients will receive three different stimulations Receives: Other: no stimulation |
| Beta (25-30 Hz) | Other | Vagal nerve stimulator will be set to Beta (25-30 Hz) Receives: Other: beta (25-30 Hz) |
| Theta (5 Hz) | Other | Vagal nerve stimulator will be set to Theta (5 Hz) Receives: Other: Theta (5 Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal and Learning Test 2nd edition group 1
Test scored with lower values indicating worse memory and higher values indicating better memory.
Minimum Value:
-16
Maximum Value:
16
Measured: hour 1.5
California Verbal and Learning Test 2nd edition group 2
Test scored with lower values indicating worse memory and higher values indicating better memory.
Minimum Value:
-16
Maximum Value:
16
Measured: hour 2.25
California Verbal and Learning Test 2nd edition group 3
Test scored with lower values indicating worse memory and higher values indicating better memory.
Minimum Value:
-16
Maximum Value:
16
Measured: hour 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start6 Jan 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Why it stopped: insufficient study staff
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 University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Pilot Study
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiarash Shahlaie, M.D., Ph.D., University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331939
- Sponsor's protocol ID
- 938884
- Status last verified
- Oct 2017
- First submitted
- 1 Nov 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- 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 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Theta Frequency Stimulation of the Vagus Nerve on Cognition : a Pilot Study
- ClinicalTrials.gov ID
- NCT03331939
- Acronym / sponsor ID
- 938884
- Conditions
- Refractory Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient study staff
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 6 Nov 2017 (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 investigation is data pilot study of the effect of theta frequency stimulation of the vagus nerve on cognitive performance in patients with refractory epilepsy. We will compare the effects of no stimulation, theta frequency (5 Hz), and 'standard' beta frequency stimulation (25-30 Hz) on cognitive measures. We hypothesize that theta frequency VNS will have a positive effect on memory retention. The goal of this study to provide initial data to inform the design of a larger clinical trial to examine the efficacy of theta VNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pilot Study
| Arm | Type | Receives |
|---|---|---|
| No stimulation | Experimental | Other: no stimulationAll patients will receive three different stimulations |
| Beta (25-30 Hz) | Other | Other: beta (25-30 Hz)Vagal nerve stimulator will be set to Beta (25-30 Hz) |
| Theta (5 Hz) | Other | Other: Theta (5 Hz)Vagal nerve stimulator will be set to Theta (5 Hz) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Refractory Epilepsy
- Previously implanted vagal nerve stimulator
- Willingness and ability to undergo temporary changes to their VNS device settings
Key exclusion criteria (10 listed)
- <18 years of age
- Adults unable to consent
- Pregnant women
- Prisoners
- >20 on the Beck Depression Inventory (BDI)
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 |
|---|---|---|
| no stimulationVagal nerve stimulator will be set to no stimulation | Other | No stimulation |
| beta (25-30 Hz)Vagal nerve stimulator will be set to beta (25-30 Hz) | Other | Beta (25-30 Hz) |
| Theta (5 Hz)Vagal nerve stimulator will be set to beta (5 Hz) | Other | Theta (5 Hz) |
Primary outcome
California Verbal and Learning Test 2nd edition group 1
Time frame: hour 1.5
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
California Verbal and Learning Test 2nd edition group 2
Time frame: hour 2.25
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
California Verbal and Learning Test 2nd edition group 3
Time frame: hour 3
Test scored with lower values indicating worse memory and higher values indicating better memory. Minimum Value: -16 Maximum Value: 16
Results and safety
The study was stopped early (reason given: insufficient study staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing no stimulation, beta (25-30 Hz) and Theta (5 Hz) in people with Refractory Epilepsy, run by University of California, Davis.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Nov 2017. 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 stopped early (reason given: insufficient study staff). Results are not available in the source record.
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?
California Verbal and Learning Test 2nd edition group 1 (time frame: hour 1.5). The study lists 3 primary outcomes in all. 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 6 Nov 2017.