Clinical trial NCT00212745: Pilot Trial of a Behavioral Treatment for Epilepsy
Official title: Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Epilepsies, Partial
Keywords: Behavior Therapy
Relaxation Techniques
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Seizure frequency
timeFrame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary outcomes:
measure: Epileptiform EEG changes
timeFrame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
measure: Heartrate variability
timeFrame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
measure: Salivary cortisol
timeFrame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
measure: Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life
timeFrame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Siegward M Elsas, M.D.
role: PRINCIPAL_INVESTIGATOR
References: