Pilot Trial of a Behavioral Treatment for Epilepsy

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Epilepsies, Partial

Treatments: Behavioral: Andrews/Reiter behavioral treatment for epilepsy

Study type: Interventional

Funder types: Other

Identifiers

NCT00212745

MRF #0425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

2

No Intervention group

Description:

Receives only EEG and questionnaire testing, no behavioral intervention or meditative relaxation

1

Experimental group

Description:

Andrews/Reiter behavioral treatment for epilepsy and EEG and questionnaire testing

Treatment:

Behavioral: Andrews/Reiter behavioral treatment for epilepsy