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Pilot Trial of a Behavioral Treatment for Epilepsy

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Andrews/Reiter behavioral treatment for epilepsy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies, Partial focused on measuring Behavior Therapy, Relaxation Techniques

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

1

Arm Description

Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation

Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Epileptiform EEG changes
Heartrate variability
Salivary cortisol
Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life

Full Information

First Posted
September 13, 2005
Last Updated
July 30, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00212745
Brief Title
Pilot Trial of a Behavioral Treatment for Epilepsy
Official Title
Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Behavior Therapy, Relaxation Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Description
Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation
Arm Title
1
Arm Type
Experimental
Arm Description
Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing
Intervention Type
Behavioral
Intervention Name(s)
Andrews/Reiter behavioral treatment for epilepsy
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
Heartrate variability
Time Frame
At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Title
Salivary cortisol
Time Frame
At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siegward M Elsas, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Pilot Trial of a Behavioral Treatment for Epilepsy

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