EpilepsyNCT00597285
Relationship of HHV-6B Virus to Seizures and Brain Injury
An observational study of Epilepsy and HHV6B Infection, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will look for evidence that a virus called HHV-6B may be related to seizures and to a form of brain injury called mesial temporal sclerosis that is associated with seizures. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, HHV6B Infection
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2008to 1 Nov 2013
- Phase
- Observational
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients will be avaluated for participation under screening protocol 01-N-0139.
- Patients
- Male and female subjects age 18 to 55
- Subjects with seizures uncontrolled by antiepileptic drugs
- Subjects with no other illnesses, or taking other substances or medicines that could interfere with the study
- Healthy Controls
- Male and female subjects age 18 to 55.
Who cannot join
- Patient
- Subjects who are pregnant or breast feeding.
- Subjects with any medical condition that could interfere with the study.
- Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin.
- Healthy Volunteers
- Subjects who are pregnant or breast feeding
- Subjects who have any medical condition or be taking any substance or medication that could interfere with the study
- Subjects who are taking drugs that significantly reduce blood cloting such as Coumadin or Warfarin
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: HHV6B in Epilepsy Imaging and CSF Studies
This study will look for evidence that a virus called HHV-6B may be related to seizures and to a form of brain injury called mesial temporal sclerosis that is associated with seizures. The study will use new, more sensitive brain scans to try to detect brain regions that might be affected by the virus and will examine cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord) for evidence of the virus as well.
Healthy volunteers and people with seizures uncontrolled by anti-epileptic drugs who are between 18 and 45 years of age may be eligible for this study. Candidates are screened with a physical examination and laboratory tests.
Read more
Participants undergo the following procedures:
- PET scan. This test uses a radioactive chemical called 18FDG, which is detected by the PET scanner to obtain images of the brain. The subject lies on a table with his or her head positioned in the scanner. A swimming cap with a small light reflector is placed on the head to monitor the position of the head during the scan. A catheter (plastic tube) is inserted into an artery at the wrist or elbow crease of the arm for obtaining blood samples during the scan, and a second catheter is placed in a vein in the other arm for injecting the 18FDG. The scan takes up to 2 hours. A second scan may be done over an additional 15 minutes.
- MRI. This test uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies on a table that can slide in and out of a metal cylinder surrounded by a magnetic field. Most scans last between 45 and 90 minutes.
- Lumbar puncture. The subject sits upright or lies on a table with the knees curled to the chest for this procedure. A local anesthetic is injected to numb the skin and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.
- Blood tests. About 4 tablespoons of blood are drawn for viral tests.
Read the detailed description
Objectives: 1) to attempt to detect specific patterns of hippocampal injury in patients with temporal lobe epilepsy that may be associated with HHV-6B infection; 2) To attempt to detect evidence for persistent HHV6 infection in CSF in patients with refractory temporal lobe epilepsy. 3) to obtain preliminary pilot data on the ability of high resolution structural to detect abnormalities in epilepsy patients not seen with standard scanners.
Study Population: 45 patients with localization-related epilepsy; 45 healthy volunteers
Design: 1) imaging with a 7T MRI magnetic resonance scanner; 2) Lumbar puncture. 3) blood sampling
Main outcome measure: 1) Detection of evidence for HHV6 infection in CSF
- Conditions
- Epilepsy, HHV6B Infection
- Keywords
- 18-F-Fluoro-2-Deoxy-D-Glucose (FDG), Magnetic Resonance, Epilepsy, HHV-6B, Healthy Volunteer, HV
- Medical subject headings
- Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of evidence for HHV6 infection in CSF
Secondary outcomes (1)
Detection of lesions on 7T compared to 3T MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study start3 Jan 2008
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- William H Theodore, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597285
- Sponsor's protocol ID
- 080027
- Other IDs
- 08-N-0027
- Status last verified
- 1 Nov 2013
- First submitted
- 8 Jan 2008
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
PubMed 9092951Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51. doi: 10.1111/j.1528-1157.2000.tb00166.x.
PubMed 10714408Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, Smith S. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006 Jul;60(1):73-9. doi: 10.1002/ana.20852.
PubMed 16685695
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HHV6B in Epilepsy Imaging and CSF Studies
- ClinicalTrials.gov ID
- NCT00597285
- Acronym / sponsor ID
- 080027
- Conditions
- Epilepsy, HHV6B Infection
- Keywords
- 18-F-Fluoro-2-Deoxy-D-Glucose (FDG), Magnetic Resonance, Epilepsy, HHV-6B, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 3 Jan 2008
- Study completion
- 1 Nov 2013
- First posted
- 18 Jan 2008 (estimated)
- 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.
This study will look for evidence that a virus called HHV-6B may be related to seizures and to a form of brain injury called mesial temporal sclerosis that is associated with seizures. The study will use new, more sensitive brain scans to try to detect brain regions that might be affected by the virus and will examine cerebrospinal fluid (CSF, the fluid that bathes the brain and spinal cord) for evidence of the virus as well.
Healthy volunteers and people with seizures uncontrolled by anti-epileptic drugs who are between 18 and 45 years of age may be eligible for this study. Candidates are screened with a physical examination and laboratory tests.
Participants undergo the following procedures:
- PET scan. This test uses a radioactive chemical called 18FDG, which is detected by the PET scanner to obtain images of the brain. The subject lies on a table with his or her head positioned in the scanner. A swimming cap with a small light reflector is placed on the head to monitor the position of the head during the scan. A catheter (plastic tube) is inserted into an artery at the wrist or elbow crease of the arm for obtaining blood samples during the scan, and a second catheter is placed in a vein in the other arm for injecting the 18FDG. The scan takes up to 2 hours. A second scan may be done over an additional 15 minutes.
- MRI. This test uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies on a table that can slide in and out of a metal cylinder surrounded by a magnetic field. Most scans last between 45 and 90 minutes.
- Lumbar puncture. The subject sits upright or lies on a table with the knees curled to the chest for this procedure. A local anesthetic is injected to numb the skin and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle.
- Blood tests. About 4 tablespoons of blood are drawn for viral tests.
Detailed description
Objectives: 1) to attempt to detect specific patterns of hippocampal injury in patients with temporal lobe epilepsy that may be associated with HHV-6B infection; 2) To attempt to detect evidence for persistent HHV6 infection in CSF in patients with refractory temporal lobe epilepsy. 3) to obtain preliminary pilot data on the ability of high resolution structural to detect abnormalities in epilepsy patients not seen with standard scanners.
Study Population: 45 patients with localization-related epilepsy; 45 healthy volunteers
Design: 1) imaging with a 7T MRI magnetic resonance scanner; 2) Lumbar puncture. 3) blood sampling
Main outcome measure: 1) Detection of evidence for HHV6 infection in CSF
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients will be avaluated for participation under screening protocol 01-N-0139.
- Patients
- Male and female subjects age 18 to 55
- Subjects with seizures uncontrolled by antiepileptic drugs
- Subjects with no other illnesses, or taking other substances or medicines that could interfere with the study
Key exclusion criteria (8 listed)
- Patient
- Subjects who are pregnant or breast feeding.
- Subjects with any medical condition that could interfere with the study.
- Subjects who are taking drugs that significantly reduce blood clotting such as Coumadin or Warfarin.
- Healthy Volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of evidence for HHV6 infection in CSF
1 secondary outcome
Detection of lesions on 7T compared to 3T MRI
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 9092951Baker GA, Nashef L, van Hout BA. Current issues in the management of epilepsy: the impact of frequent seizures on cost of illness, quality of life, and mortality. Epilepsia. 1997;38 Suppl 1:S1-8. doi: 10.1111/j.1528-1157.1997.tb04511.x.
- Background: PubMed 10714408Begley CE, Famulari M, Annegers JF, Lairson DR, Reynolds TF, Coan S, Dubinsky S, Newmark ME, Leibson C, So EL, Rocca WA. The cost of epilepsy in the United States: an estimate from population-based clinical and survey data. Epilepsia. 2000 Mar;41(3):342-51. doi: 10.1111/j.1528-1157.2000.tb00166.x.
- Background: PubMed 16685695Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, Smith S. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006 Jul;60(1):73-9. doi: 10.1002/ana.20852.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
William H Theodore, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and HHV6B Infection, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 7 inclusion and 8 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 16 Dec 2019. 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?
The study was stopped early. 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?
Detection of evidence for HHV6 infection in CSF. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597285, which also lists 3 linked publications.
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 16 Dec 2019.