Pilot Trial of a Behavioral Treatment for Epilepsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 2 Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation |
|
| Experimental: 1 Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing |
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.
|
Outcome Measures
Primary Outcome Measures
- Seizure frequency [At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.]
Secondary Outcome Measures
- Epileptiform EEG changes [At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.]
- Heartrate variability [At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.]
- Salivary cortisol [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 [At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 16-50 years.
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Reliable diagnosis of partial epilepsy, including simple or complex partial or secondarily generalized tonic-clonic seizures.
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Average seizure frequency of at least one partial seizure per month for at least one year.
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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.
Exclusion Criteria:
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Unreliable history of seizure semiology.
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Average seizure frequency less than one seizure per month.
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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.
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Patients taking more than 2 anticonvulsant medications will be excluded.
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Patients with serious other medical problems, such as brain tumors, cancer, stroke, significant heart disease or psychiatric disorders will be excluded.
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Patients with a high likelihood of psychogenic or nonepileptic seizures will be excluded.
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Patients with progressive epilepsy syndromes, neurodegenerative disorders or significant mental retardation will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
- Principal Investigator: Siegward M Elsas, M.D., Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRF #0425
- MRF #0425