A Study of Meditation as a Treatment for Epilepsy | NCT00370929

Studies
A Study of Meditation as a Treatment for Epilepsy

NCT00370929

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Jul 22, 2016Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Meditation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Sep 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2016

Last Update Posted Date

Jul 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Stern, Principal Investigator, University of California, Los AngelesPrincipal Investigator

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Epileptic seizures may occur at times of stress and commonly increase life stress. This study will evaluate whether meditation improves seizure control and quality of life for individuals with uncontrolled epilepsy.

Detailed Description

Individuals who have uncontrolled epilepsy commonly experience disability, depression, anxiety and injuries from seizures. For such individuals, ideal treatments should improve quality of life through control of seizures and improved emotional state. Meditation with cultivation of emotional balance is known to improve emotional state and may also benefit seizure control in some individuals. In this study, individuals with uncontrolled epilepsy will receive detailed training in meditation to determine whether the training leads to improvements in seizure control and various measures of emotion and quality of life.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
Meditation	Experimental		Behavioral: Meditation

Name	Type	Description	Arm Group Labels	Other Names
Meditation	Behavioral		Meditation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seizure frequency		20 weeks
Quality of Life		20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mood		20 weeks
Affect		20 weeks
Anxiety		20 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 or more seizures per month
ability to participate in meditation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Stern, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geffen School of Medicine at UCLA		Los Angeles	California	90095	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019122	Meditation

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided