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Pilot Trial of a Behavioral Treatment for Epilepsy

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212745
Enrollment
8
Registered
2005-09-21
Start date
2004-02-29
Completion date
2009-03-31
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial

Keywords

Behavior Therapy, Relaxation Techniques

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.

Interventions

BEHAVIORALAndrews/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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frame
Seizure frequencyAt enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

Secondary

MeasureTime frame
Epileptiform EEG changesAt enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Heartrate variabilityAt enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.
Salivary cortisolAt 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 lifeAt enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026