Pilot Trial of a Behavioral Treatment for Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00212745
First received: September 13, 2005
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonrandomized Pilot Trial of the Andrews/Reiter Behavioral Treatment for Epilepsy

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Seizure frequency [ Time Frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Heartrate variability [ Time Frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment. ] [ Designated as safety issue: No ]
  • Salivary cortisol [ Time Frame: At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2004
Estimated Study Completion Date: March 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Siegward-M. Elsas, M.D., Orgeon Health & Science University
ClinicalTrials.gov Identifier: NCT00212745     History of Changes
Other Study ID Numbers: MRF #0425, MRF #0425
Study First Received: September 13, 2005
Last Updated: September 22, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014