Pilot Trial of a Behavioral Treatment for Epilepsy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00212745
First received: September 13, 2005
Last updated: September 22, 2009
Last verified: September 2009
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | September 22, 2009 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Seizure frequency [ Time Frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment. ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Seizure frequency at enrollment, end of baseline, and after 6 months of treatment. | ||||
| Change History | Complete list of historical versions of study NCT00212745 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Trial of a Behavioral Treatment for Epilepsy | ||||
| Official Title ICMJE | Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Epilepsies, Partial | ||||
| Intervention ICMJE | Behavioral: Andrews/Reiter behavioral treatment for epilepsy
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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 8 | ||||
| Estimated Completion Date | March 2010 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00212745 | ||||
| Other Study ID Numbers ICMJE | MRF #0425, MRF #0425 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Siegward-M. Elsas, M.D., Orgeon Health & Science University | ||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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