Yoga for Patients With Epilepsy

March 9, 2017 updated by: Kaarkuzhali Babu Krishnamurthy, Beth Israel Deaconess Medical Center

Is Yoga Safe for Patients With Epilepsy?

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will keep logs of seizure frequency prior to, during, and following training in a yoga regimen. Instruction in the yoga regimen will occur at BIDMC, and home practice following classroom instruction will occur as part of the study. Side effects, changes in seizure frequency, and quality of life assessments will be performed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Subjects invited to participate in yoga practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life assessments.
Time Frame: 3 months
3 months
Improvement in mood.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in seizure control.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kaarkuzhali Krishanmurthy, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2003P000337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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