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Pilot Trial of a Behavioral Treatment for Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00212745
Recruitment Status : Unknown
Verified September 2009 by Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Behavioral: Andrews/Reiter behavioral treatment for epilepsy Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy
Study Start Date : February 2004
Primary Completion Date : March 2009
Estimated Study Completion Date : March 2010


Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212745


Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Siegward M Elsas, M.D. Oregon Health and Science University
More Information

Responsible Party: Siegward-M. Elsas, M.D., Orgeon Health & Science University
ClinicalTrials.gov Identifier: NCT00212745     History of Changes
Other Study ID Numbers: MRF #0425
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009

Keywords provided by Oregon Health and Science University:
Behavior Therapy
Relaxation Techniques

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases