Pilot Trial of a Behavioral Treatment for Epilepsy

Phase 1

Completed

• Conditions: Epilepsies, Partial
• Interventions: Behavioral: Andrews/Reiter behavioral treatment for epilepsy

• Registration Number: NCT00212745
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Andrews/Reiter behavioral treatment for epilepsy	Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Salivary cortisol	At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States