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

September 13, 2005
September 22, 2009
February 2004
March 2009   (final data collection date for primary outcome measure)
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 ]
Seizure frequency at enrollment, end of baseline, and after 6 months of treatment.
Complete list of historical versions of study NCT00212745 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Epileptiform EEG changes
  • Heartrate variability
  • Salivary cortisol
  • Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life
  • All are collected at enrollment, end of baseline, and after 6 months of treatment.
Not Provided
Not Provided
 
Pilot Trial of a Behavioral Treatment for Epilepsy
Nonrandomized Pilot Trial of the Andrews/Reiter 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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsies, Partial
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.
  • 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
    Intervention: Behavioral: Andrews/Reiter behavioral treatment for epilepsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8
March 2010
March 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00212745
MRF #0425, MRF #0425
Yes
Siegward-M. Elsas, M.D., Orgeon Health & Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Siegward M Elsas, M.D. Oregon Health and Science University
Oregon Health and Science University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP