Pilot Trial of a Behavioral Treatment for Epilepsy

NCT ID: NCT00212745

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-03-31

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.

Conditions

Epilepsies, Partial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

1

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

Group Type: EXPERIMENTAL

Andrews/Reiter behavioral treatment for epilepsy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siegward M Elsas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

MRF #0425

Identifier Type: -

Identifier Source: secondary_id

MRF #0425

Identifier Type: -

Identifier Source: org_study_id