Pilot Trial of a Behavioral Treatment for Epilepsy

Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial
• Intervention / Treatment: Behavioral: Andrews/Reiter behavioral treatment for epilepsy

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 21, 2005

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Behavior Therapy; Relaxation Techniques
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: MRF #0425