EpilepsyPhase 2NCT00067210
Reducing Seizure Frequency Using Cooling of the Head and Neck
A Phase 2 study testing Head and Neck Cooling System in people with Epilepsy and Seizures, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery. The purpose of this study is to assess a head-neck cooling device that the patient can wear. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- What is being tested?
- Head and Neck Cooling System
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2003to 22 May 2007
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A minimum of one documented seizure of any type per a 1-week period.
- 21 years or older, and able to cooperate with the cooling procedures.
- On a stable antiepileptic drug (AED) regimen, as determined by history and by AED plasma levels as measured in the CC OPD.
- The ability to maintain a daily seizure calendar, either independently or with help from a family member.
- No history of intestinal problems or history of intestinal surgery.
- Must be able to swallow medication in capsule form.
Who cannot join
- Female patients who are pregnant.
- Those patients under 21 years of age.
- Those patients who may have difficulty swallowing a large capsule, or describing their feelings and experiences related to the cooling sessions.
- Those patients with a history of intestinal problems or intestinal surgery
- Those patients with progressive neurological disorders
- Those sensitive to coldness
- History of severe 'ice-cream' headache
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: Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study
Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery.
The purpose of this study is to assess a head-neck cooling device that the patient can wear. Researchers will determine whether the device can change the frequency of seizures in people with epilepsy.
Study participants must be 21 years of age or older and must experience seizures that occur once a week on a regular basis. Participants will be asked to keep a detailed seizure diary for a 12-week period before the date of the first cooling session. For each of the four cooling sessions, participants will be admitted to the hospital overnight. They will undergo a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a temperature-sensor pill. Participants will have one 60-minute cooling session once a week for 4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm, abdomen, and leg. Participants will then be fitted with the cooling unit and the session will begin.
Read the detailed description
Previous experimental as well as clinical reports have clearly shown that cooling of the brain does have inhibitory effects on epileptiform discharges and seizures. We hypothesize that mild cooling of the brain has anti-epileptic effects in epileptic patients who either have no identifiable seizure foci, who have multiple foci, or who have frequent localization-related seizures that are refractory to antiepileptic drugs. We have studied the feasibility and safety of a head-neck cooling device in 10 adult normal volunteers, and found that the head-neck cooling was feasible and safe, without significant complaints or problems voiced by the subjects. Overall, a slight reduction of core temperature was shown. Since cooling on a twice-a-week basis was well tolerated by normal volunteers, we would like to extend our study to patients with epilepsy to learn the optimal duration and frequency of head-neck cooling in terms of reducing seizure frequency. This will be a pilot study, as directed by PIRC and the IRB, in which we will evaluate 60 minutes of cooling performed once a week for 4 weeks in 5 epileptic patients. We will then report the results to PIRC and the IRB before we proceed with further study.
- Being tested
- Head and Neck Cooling System
- Keywords
- Brain, Epilepsy, Core, Temperature
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and Neck Cooling SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study start11 Aug 2003
- Study completion22 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 5 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067210
- Sponsor's protocol ID
- 030272
- Other IDs
- 03-N-0272
- Status last verified
- 13 Jun 2008
- First submitted
- 12 Aug 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Cabanac M. Selective brain cooling in humans: "fancy" or fact? FASEB J. 1993 Sep;7(12):1143-6; discussion 1146-7. doi: 10.1096/fasebj.7.12.8375612.
PubMed 8375612
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study
- ClinicalTrials.gov ID
- NCT00067210
- Acronym / sponsor ID
- 030272
- Keywords
- Brain, Epilepsy, Core, Temperature
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Aug 2003
- Study completion
- 22 May 2007
- First posted
- 13 Aug 2003 (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.
Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery.
The purpose of this study is to assess a head-neck cooling device that the patient can wear. Researchers will determine whether the device can change the frequency of seizures in people with epilepsy.
Study participants must be 21 years of age or older and must experience seizures that occur once a week on a regular basis. Participants will be asked to keep a detailed seizure diary for a 12-week period before the date of the first cooling session. For each of the four cooling sessions, participants will be admitted to the hospital overnight. They will undergo a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a temperature-sensor pill. Participants will have one 60-minute cooling session once a week for 4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm, abdomen, and leg. Participants will then be fitted with the cooling unit and the session will begin.
Detailed description
Previous experimental as well as clinical reports have clearly shown that cooling of the brain does have inhibitory effects on epileptiform discharges and seizures. We hypothesize that mild cooling of the brain has anti-epileptic effects in epileptic patients who either have no identifiable seizure foci, who have multiple foci, or who have frequent localization-related seizures that are refractory to antiepileptic drugs. We have studied the feasibility and safety of a head-neck cooling device in 10 adult normal volunteers, and found that the head-neck cooling was feasible and safe, without significant complaints or problems voiced by the subjects. Overall, a slight reduction of core temperature was shown. Since cooling on a twice-a-week basis was well tolerated by normal volunteers, we would like to extend our study to patients with epilepsy to learn the optimal duration and frequency of head-neck cooling in terms of reducing seizure frequency. This will be a pilot study, as directed by PIRC and the IRB, in which we will evaluate 60 minutes of cooling performed once a week for 4 weeks in 5 epileptic patients. We will then report the results to PIRC and the IRB before we proceed with further study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A minimum of one documented seizure of any type per a 1-week period.
- 21 years or older, and able to cooperate with the cooling procedures.
- On a stable antiepileptic drug (AED) regimen, as determined by history and by AED plasma levels as measured in the CC OPD.
- The ability to maintain a daily seizure calendar, either independently or with help from a family member.
- No history of intestinal problems or history of intestinal surgery.
Key exclusion criteria (7 listed)
- Female patients who are pregnant.
- Those patients under 21 years of age.
- Those patients who may have difficulty swallowing a large capsule, or describing their feelings and experiences related to the cooling sessions.
- Those patients with a history of intestinal problems or intestinal surgery
- Those patients with progressive neurological disorders
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 |
|---|---|---|
| Head and Neck Cooling System | Device | – |
Primary outcome
Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.
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 2 Jul 2017.
- Background: PubMed 8375612Cabanac M. Selective brain cooling in humans: "fancy" or fact? FASEB J. 1993 Sep;7(12):1143-6; discussion 1146-7. doi: 10.1096/fasebj.7.12.8375612.
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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?
A Phase 2 study testing Head and Neck Cooling System in people with Epilepsy and Seizures, 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 6 inclusion and 7 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 2 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.. 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 NCT00067210, which also lists 1 linked publication.
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 2 Jul 2017.