Pilot Trial of a Behavioral Treatment for Epilepsy

Epilepsies, Partial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212745
• Other study ID #: MRF #0425
• Secondary ID: MRF #0425
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2004
• Est. completion date: March 2009

Study information

• Verified date: July 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency		At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary	Epileptiform EEG changes		At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary	Heartrate variability		At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary	Salivary cortisol		At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Secondary	Questionnaires on stress, emotional well-being, self-efficacy, sleepiness and quality of life		At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.