Overview

This trial is active, not recruiting.

Condition epilepsies, partial
Treatment andrews/reiter behavioral treatment for epilepsy
Phase phase 1/phase 2
Sponsor Oregon Health and Science University
Start date February 2004
End date March 2009
Trial size 8 participants
Trial identifier NCT00212745, MRF #0425

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation
(Experimental)
Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing
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.

Primary Outcomes

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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants from 16 years up to 50 years old.

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.

Additional Information

Official title Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
Principal investigator Siegward M Elsas, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.