Epilepsies, PartialPhase 1/2NCT00212745
Pilot Trial of a Behavioral Treatment for Epilepsy
A Phase 1/2 study testing Andrews/Reiter behavioral treatment for epilepsy in people with Epilepsies, Partial, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this research study is to see if a behavioral program which includes a relaxation technique and lifestyle changes can improve seizure control and well-being in epilepsy patients. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Andrews/Reiter behavioral treatment for epilepsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2009
- Phase
- Phase 1/2
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-50 years.
- Reliable diagnosis of partial epilepsy, including simple or complex partial or secondarily generalized tonic-clonic seizures.
- Average seizure frequency of at least one partial seizure per month for at least one year.
- Willing not to begin another new treatment other than anticonvulsants (acupuncture, botanicals or other mind-body interventions, ketogenic diet, vagus nerve stimulator, or epilepsy surgery) while enrolled in the study.
Who cannot join
- Unreliable history of seizure semiology.
- Average seizure frequency less than one seizure per month.
- Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded.
- Patients taking more than 2 anticonvulsant medications will be excluded.
- Patients with serious other medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders will be excluded.
- Patients with a high likelihood of psychogenic or nonepileptic seizures will be excluded.
- Patients with progressive epilepsy syndromes, neurodegenerative disorders or significant mental retardation will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
The purpose of this research study is to see if a behavioral program which includes a relaxation technique and lifestyle changes can improve seizure control and well-being in epilepsy patients.
Read the detailed description
The behavioral treatment approach studied aims to help epilepsy patients discover which circumstances and behaviors trigger their seizures. The most common seizure precipitants are irregularities of sleep, sensory triggers such as flashing lights and emotional stress. Patients will learn how to avoid seizure precipitants and how to stop seizures in their first beginnings. Study participants will continue their prior medications.
- Conditions
- Epilepsies, Partial
- Being tested
- Andrews/Reiter behavioral treatment for epilepsy
- Keywords
- Behavior Therapy, Relaxation Techniques
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrews/Reiter behavioral treatment for epilepsyBehavioural
The behavioral intervention in this study uses lifestyle counseling to avoid triggers for seizures and strategies to stop beginning seizures. Participants are taught to practice meditative relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation |
| 1 | Experimental | Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing Receives: Behavioral: Andrews/Reiter behavioral treatment for epilepsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Measured: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary outcomes (4)
Epileptiform EEG changes
Measured: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Heartrate variability
Measured: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Salivary cortisol
Measured: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life
Measured: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siegward M Elsas, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212745
- Sponsor's protocol ID
- MRF #0425
- Other IDs
- MRF #0425
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2005
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
- ClinicalTrials.gov ID
- NCT00212745
- Acronym / sponsor ID
- MRF #0425
- Conditions
- Epilepsies, Partial
- Keywords
- Behavior Therapy, Relaxation Techniques
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this research study is to see if a behavioral program which includes a relaxation technique and lifestyle changes can improve seizure control and well-being in epilepsy patients.
Detailed description
The behavioral treatment approach studied aims to help epilepsy patients discover which circumstances and behaviors trigger their seizures. The most common seizure precipitants are irregularities of sleep, sensory triggers such as flashing lights and emotional stress. Patients will learn how to avoid seizure precipitants and how to stop seizures in their first beginnings. Study participants will continue their prior medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation |
| 1 | Experimental | Behavioral: Andrews/Reiter behavioral treatment for epilepsyAndrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-50 years.
- Reliable diagnosis of partial epilepsy, including simple or complex partial or secondarily generalized tonic-clonic seizures.
- Average seizure frequency of at least one partial seizure per month for at least one year.
- Willing not to begin another new treatment other than anticonvulsants (acupuncture, botanicals or other mind-body interventions, ketogenic diet, vagus nerve stimulator, or epilepsy surgery) while enrolled in the study.
Key exclusion criteria (7 listed)
- Unreliable history of seizure semiology.
- Average seizure frequency less than one seizure per month.
- Patients in whom it is anticipated that current standard of care would mandate a change in their conventional epilepsy treatment during the time period of the study will be excluded.
- Patients taking more than 2 anticonvulsant medications will be excluded.
- Patients with serious other medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders will be excluded.
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 |
|---|---|---|
| Andrews/Reiter behavioral treatment for epilepsyThe behavioral intervention in this study uses lifestyle counseling to avoid triggers for seizures and strategies to stop beginning seizures. Participants are taught to practice meditative relaxation exercises. | Behavioural | 1 |
Primary outcome
Seizure frequency
Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
4 secondary outcomes
Epileptiform EEG changes
Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Heartrate variability
Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Salivary cortisol
Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life
Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
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 1 Aug 2019.
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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.
Siegward M Elsas, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Andrews/Reiter behavioral treatment for epilepsy in people with Epilepsies, Partial, run by Oregon Health and Science University 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 4 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 1 Aug 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Seizure frequency (time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.). 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 1 Aug 2019.