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Completed

NCT Number: NCT00212745

Pilot Trial of a 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.

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Key information

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Andrews/Reiter behavioral treatment for epilepsy

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.

Primary outcomes

  1. 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

  1. 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.

  2. Heartrate variability

    Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

  3. Salivary cortisol

    Time frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

  4. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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