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Clinical Trials/NCT00212745
NCT00212745
Completed
Phase 1

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

Oregon Health and Science University1 site in 1 country8 target enrollmentStarted: February 2004Last updated:
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ConditionsEpilepsies, Partial

Overview

Phase
Phase 1
Status
Completed
Enrollment
8
Locations
1
Primary Endpoint
Seizure frequency
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

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
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 50 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Epileptiform EEG changes(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)
  • Heartrate variability(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)
  • 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.)
  • Salivary cortisol(At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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