- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179452
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
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
-
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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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:
- 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.
Exclusion Criteria:
- 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.
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
Additional Relevant MeSH Terms
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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