EpilepsyNCT00085683
Herpes Virus-6 and Epilepsy
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jul 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients will have a seizure disorder as documented by EEG and video-EEG. Half of the patients will have radiologically documented mesial temporal sclerosis and the other half will have a brain MRI without mesial temporal sclerosis. The patients can only be on phenytoin, carbamazepine, oxcarbazepine, lamotrigine or levetiracetam, since these anti-epileptic drugs have the least or no effect on the glutamate and GABA levels in the brain. The patients can not take any other medications.
- Healthy control subjects entering the study must be free of serious disease as determined by a standard physical and neurological examination. The control subjects can not be on any medication.
- All subjects must be able to give informed consent allowing us to use the cerebrospinal fluid and serum for research.
- All subjects will have to be able to refrain from chocolate, tea and coffee (low monoamine diet; Wood et al.1979) and alcohol during the one week before the study.
- Patients must be seizure free for 48 hours prior to the lumbar tap and the MRS.
Who cannot join
- Subjects will be excluded if:
- They are under the age of 18
- They are female and are pregnant
- They have a history of medical disorders which can affect the concentration of cerebral metabolites, including diabetes mellitus, renal dysfunction, hepatic dysfunction and electrolyte abnormality
- They take any medication for the normal control group
- They take any medication, with the exception of phenytoin, carbamazepine, oxcarbazepine, lamotrigine and levetiracetam for the epilepsy patients
Show all 11Show fewer
- They have a history of psychiatric and/or mood disorders
- They have implanted devices such as pacemakers, medication pumps or defibrillators, or metal in the cranium except for the mouth, intra-cardiac lines, a history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI
- They have a coagulopathy that prevents them from having a lumbar puncture performed
- They have had a seizure 48 hours prior to the MRS and the lumbar tap
- Subjects who cannot give informed consent allowing us to use the removed fluid for research will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Human Herpesvirus-6 and Its Effect on the GABA/Glutamate Balance in the Cerebrospinal Fluid and in the Brain From Patients With Epilepsy
This study will explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. The virus is also thought possibly to interfere with neurotransmitters - chemicals that brain cells use to communicate with each other. This study will measure levels of two of these chemicals, GABA and glutamate, which are believed to play a role in the development of seizures.
Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control subjects 18 years of age and older may be eligible for this study. Control subjects may not be taking any medication on a regular basis. Epilepsy patients may take only phenytoin, carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a physical examination and blood tests.
Read more
Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar puncture (spinal tap).
Blood Draw
Up to four teaspoons of blood are drawn through a needle in the arm for this study.
MRI
MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which time the subject can communicate with the technician.
Lumbar Puncture
For this test the subject sits upright or lies on his or her side with knees curled at the chest. A local anesthetic is injected at the lower back, and a needle is inserted in the space between the bones where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Collection of the fluid usually takes from 5 to 20 minutes.
Read the detailed description
Objective: We would like to demonstrate with this study that the human herpesvirus-6 plays a role in the development of mesial temporal sclerosis (MTS) resulting in epilepsy. We would also like to examine what influence the virus has on the neurotransmitters glutamate and GABA, since we believe that an imbalance of the major excitatory and inhibitory neurotransmitters plays an important role in epilepsy.
Study population: The study population will consist of adult patients with epilepsy and MTS and adult patients with epilepsy and no MTS as confirmed on magnetic resonance (MR) imaging scan of the brain. We will compare findings in these two groups to those in healthy adult volunteers.
Design: This is a natural history study in which we will demonstrate the presence or absence of human herpesvirus-6 in the serum and cerebrospinal fluid (CSF) obtained from each of three adult study groups: patients with epilepsy and MTS, patients with epilepsy and no MTS, and normal controls. We will measure in all three groups the concentration of GABA and glutamate in CSF. In all three groups we will perform proton MR spectroscopy to non-invasively measure these metabolites in the brain.
Outcome measures: The three subject groups will be compared in terms of the presence or absence of the human herpesvirus-6 in the serum and CSF and in terms of the levels of glutamate and GABA as measured in the CSF and by magnetic resonance spectroscopy of the hippocampus and temporal lobe.
- Conditions
- Epilepsy
- Keywords
- Magnetic Resonance Spectroscopy, Lumbar Puncture, Healthy Control Subjects, Mesial Temporal Sclerosis, Neuroexcitotoxicity, Seizure Disorder, Epilepsy, Healthy Volunteer, HV
- Medical subject headings
- Epilepsy, Hippocampal Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startJun 2004
- Study completionJul 2005
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.
- 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
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085683
- Sponsor's protocol ID
- 040209
- Other IDs
- 04-N-0209
- Status last verified
- Jul 2005
- First submitted
- 10 Jun 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Aronica E, Yankaya B, Jansen GH, Leenstra S, van Veelen CW, Gorter JA, Troost D. Ionotropic and metabotropic glutamate receptor protein expression in glioneuronal tumours from patients with intractable epilepsy. Neuropathol Appl Neurobiol. 2001 Jun;27(3):223-37. doi: 10.1046/j.0305-1846.2001.00314.x.
PubMed 11489142Asano Y, Yoshikawa T, Kajita Y, Ogura R, Suga S, Yazaki T, Nakashima T, Yamada A, Kurata T. Fatal encephalitis/encephalopathy in primary human herpesvirus-6 infection. Arch Dis Child. 1992 Dec;67(12):1484-5. doi: 10.1136/adc.67.12.1484.
PubMed 1336954Bernasconi N, Andermann F, Arnold DL, Bernasconi A. Entorhinal cortex MRI assessment in temporal, extratemporal, and idiopathic generalized epilepsy. Epilepsia. 2003 Aug;44(8):1070-4. doi: 10.1046/j.1528-1157.2003.64802.x.
PubMed 12887438
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Herpesvirus-6 and Its Effect on the GABA/Glutamate Balance in the Cerebrospinal Fluid and in the Brain From Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT00085683
- Acronym / sponsor ID
- 040209
- Conditions
- Epilepsy
- Keywords
- Magnetic Resonance Spectroscopy, Lumbar Puncture, Healthy Control Subjects, Mesial Temporal Sclerosis, Neuroexcitotoxicity, Seizure Disorder, Epilepsy, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2004
- Study completion
- Jul 2005
- First posted
- 11 Jun 2004 (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 explore whether the human herpes virus-6 is associated with epileptic seizures. The virus may be involved in brain scarring, called mesial temporal sclerosis, which is seen in some epilepsy patients. The virus is also thought possibly to interfere with neurotransmitters - chemicals that brain cells use to communicate with each other. This study will measure levels of two of these chemicals, GABA and glutamate, which are believed to play a role in the development of seizures.
Patients with epilepsy, with or without mesial temporal sclerosis, and healthy control subjects 18 years of age and older may be eligible for this study. Control subjects may not be taking any medication on a regular basis. Epilepsy patients may take only phenytoin, carbamazepine, oxcarbazepine, lamotrigine, or levetiracetam. Candidates are screened with a physical examination and blood tests.
Participants have blood drawn and undergo magnetic resonance imaging (MRI) and lumbar puncture (spinal tap).
Blood Draw
Up to four teaspoons of blood are drawn through a needle in the arm for this study.
MRI
MRI uses a magnetic field and radio waves to produce pictures of the brain. The scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a bed that slides into the cylinder, wearing earplugs to muffle loud noises the machine makes when the magnetic fields are switched. The scan takes about 90 to 120 minutes, during which time the subject can communicate with the technician.
Lumbar Puncture
For this test the subject sits upright or lies on his or her side with knees curled at the chest. A local anesthetic is injected at the lower back, and a needle is inserted in the space between the bones where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Collection of the fluid usually takes from 5 to 20 minutes.
Detailed description
Objective: We would like to demonstrate with this study that the human herpesvirus-6 plays a role in the development of mesial temporal sclerosis (MTS) resulting in epilepsy. We would also like to examine what influence the virus has on the neurotransmitters glutamate and GABA, since we believe that an imbalance of the major excitatory and inhibitory neurotransmitters plays an important role in epilepsy.
Study population: The study population will consist of adult patients with epilepsy and MTS and adult patients with epilepsy and no MTS as confirmed on magnetic resonance (MR) imaging scan of the brain. We will compare findings in these two groups to those in healthy adult volunteers.
Design: This is a natural history study in which we will demonstrate the presence or absence of human herpesvirus-6 in the serum and cerebrospinal fluid (CSF) obtained from each of three adult study groups: patients with epilepsy and MTS, patients with epilepsy and no MTS, and normal controls. We will measure in all three groups the concentration of GABA and glutamate in CSF. In all three groups we will perform proton MR spectroscopy to non-invasively measure these metabolites in the brain.
Outcome measures: The three subject groups will be compared in terms of the presence or absence of the human herpesvirus-6 in the serum and CSF and in terms of the levels of glutamate and GABA as measured in the CSF and by magnetic resonance spectroscopy of the hippocampus and temporal lobe.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All patients will have a seizure disorder as documented by EEG and video-EEG. Half of the patients will have radiologically documented mesial temporal sclerosis and the other half will have a brain MRI without mesial temporal sclerosis. The patients can only be on phenytoin, carbamazepine, oxcarbazepine, lamotrigine or levetiracetam, since these anti-epileptic drugs have the least or no effect on the glutamate and GABA levels in the brain. The patients can not take any other medications.
- Healthy control subjects entering the study must be free of serious disease as determined by a standard physical and neurological examination. The control subjects can not be on any medication.
- All subjects must be able to give informed consent allowing us to use the cerebrospinal fluid and serum for research.
- All subjects will have to be able to refrain from chocolate, tea and coffee (low monoamine diet; Wood et al.1979) and alcohol during the one week before the study.
- Patients must be seizure free for 48 hours prior to the lumbar tap and the MRS.
Key exclusion criteria (11 listed)
- They are under the age of 18
- They are female and are pregnant
- They have a history of medical disorders which can affect the concentration of cerebral metabolites, including diabetes mellitus, renal dysfunction, hepatic dysfunction and electrolyte abnormality
- They take any medication for the normal control group
- They take any medication, with the exception of phenytoin, carbamazepine, oxcarbazepine, lamotrigine and levetiracetam for the epilepsy patients
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 11489142Aronica E, Yankaya B, Jansen GH, Leenstra S, van Veelen CW, Gorter JA, Troost D. Ionotropic and metabotropic glutamate receptor protein expression in glioneuronal tumours from patients with intractable epilepsy. Neuropathol Appl Neurobiol. 2001 Jun;27(3):223-37. doi: 10.1046/j.0305-1846.2001.00314.x.
- Background: PubMed 1336954Asano Y, Yoshikawa T, Kajita Y, Ogura R, Suga S, Yazaki T, Nakashima T, Yamada A, Kurata T. Fatal encephalitis/encephalopathy in primary human herpesvirus-6 infection. Arch Dis Child. 1992 Dec;67(12):1484-5. doi: 10.1136/adc.67.12.1484.
- Background: PubMed 12887438Bernasconi N, Andermann F, Arnold DL, Bernasconi A. Entorhinal cortex MRI assessment in temporal, extratemporal, and idiopathic generalized epilepsy. Epilepsia. 2003 Aug;44(8):1070-4. doi: 10.1046/j.1528-1157.2003.64802.x.
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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.
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, 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 5 inclusion and 11 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 4 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00085683, 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 4 Mar 2008.