NCT00212745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

5.1 years

First QC Date

September 13, 2005

Last Update Submit

July 30, 2019

Conditions

Epilepsies, Partial

Keywords

Behavior TherapyRelaxation Techniques

Outcome Measures

Primary Outcomes (1)

  • Seizure frequency

    At enrollment, end of 2-3 month baseline, after 6 months of treatment, and 6 months after end of treatment.

Secondary Outcomes (4)

  • 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.

  • Salivary cortisol

    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.

Study Arms (2)

2

NO INTERVENTION

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

1

EXPERIMENTAL

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

Behavioral: Andrews/Reiter behavioral treatment for epilepsy

Interventions

Andrews/Reiter behavioral treatment for epilepsyBEHAVIORAL

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.

1

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Siegward M Elsas, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

February 1, 2004

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

US(1)