EpilepsyNCT00179452
Yoga for Patients With Epilepsy
A study testing Yoga in people with Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
To establish the safety and feasibility of having patients with epilepsy perform yoga. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Is Yoga Safe for Patients With Epilepsy?
To establish the safety and feasibility of having patients with epilepsy perform yoga.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects invited to participate in yoga practice. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in quality of life assessments.
Measured: 3 months
Improvement in mood.
Measured: 3 months
Secondary outcomes (1)
Improvement in seizure control.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaarkuzhali Babu Krishnamurthy, Beth Israel Deaconess Medical Center
- Investigators
- Kaarkuzhali Krishanmurthy, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179452
- Sponsor's protocol ID
- 2003P000337
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share as was not included in original protocol as approved by the IRB, so subject consent was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Yoga Safe for Patients With Epilepsy?
- ClinicalTrials.gov ID
- NCT00179452
- Acronym / sponsor ID
- 2003P000337
- Conditions
- Epilepsy
- Keywords
- epilepsy, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the safety and feasibility of having patients with epilepsy perform yoga.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: YogaSubjects invited to participate in yoga practice. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga | Behavioural | Intervention |
Primary outcome
Improvement in quality of life assessments.
Time frame: 3 months
Improvement in mood.
Time frame: 3 months
1 secondary outcome
Improvement in seizure control.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Individual participant dataSharing planned: No. No plan to share as was not included in original protocol as approved by the IRB, so subject consent was not obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaarkuzhali Krishanmurthy, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in quality of life assessments. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.