NCT00179452

Brief Summary

To establish the safety and feasibility of having patients with epilepsy perform yoga.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

September 13, 2005

Last Update Submit

March 9, 2017

Conditions

Epilepsy

Keywords

epilepsy, yoga

Outcome Measures

Primary Outcomes (2)

  • Improvement in quality of life assessments.

    3 months

  • Improvement in mood.

    3 months

Secondary Outcomes (1)

  • Improvement in seizure control.

    3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Subjects invited to participate in yoga practice.

Behavioral: Yoga

Interventions

YogaBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be able to give full informed consent.
  • Must have one or more of the following seizure types: simple partial, complex partial, or secondarily generalized.
  • Age 18-64.
  • Must have 4-20 during the baseline phase.
  • Must have medical clearance from their primary care giver sufficient to allow for participation in yoga exercises.
  • Must be stable enough to allow for all anticonvulsant levels to remain constant for the duration of the study.

You may not qualify if:

  • Having primary generalized epilepsy or atonic seizures.
  • Having a history of status epilepticus in the past two years.
  • Any medical problem that would preclude participation in a yoga class.
  • Nonepileptic or psychogenic seizures.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Yoga

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Kaarkuzhali Krishanmurthy, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

October 1, 2003

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plan to share as was not included in original protocol as approved by the IRB, so subject consent was not obtained.

Locations

US(1)