Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy

NCT01214707 | Completed

• 1 other identifier: E-31
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Characterization of the cardiac response (ECG) preceding an epileptic seizure.

Conditions

Epilepsy

Keywords

Exercise/No active Treatment

Outcome Measures

Primary Outcomes (1)

• Heart Rate Changes during Normal Activity, Exercise, and Seizures in Subjects with Epilepsy

  Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.

  3 to 5 days

Study Arms (1)

Exercise protocol

No arms are required for this study as all subjects complete the entire protocol

Other: Exercise

Interventions

Exercise OTHER

Exercise during EMU stay

Also known as: Exercise during EMU stay. No treatment intervention.

Exercise protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with epilepsy already scheduled for an EMU stay.

You may qualify if:

• Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU).
• Patient likely requires an EMU evaluation for a period of at least 3 days.
• In the opinion of the Principal Investigator, the Patient is likely to have 3 - 5 seizures during the EMU stay.
• Patient is currently taking at least one antiepileptic medication.
• Patients must be 18 years or older and may be of either sex and of any race.
• Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
• Patient must be willing and able to complete informed consent and HIPAA authorization.
• Patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures.

You may not qualify if:

• Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
• Patients experiencing status epileptic within the last 6 months.
• Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk.
• Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.
• Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation.
• Patients currently dependent on alcohol or narcotic drugs as defined by DSM IV-R.
• Patients with a history of only psychogenic seizures or pseudo seizures.
• Women who are pregnant. Women of childbearing age must take a pregnancy test.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (2)

BNI

Phoenix, Arizona, 85013, United States

Location

KUMC

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David M Treiman, MD

  Barrow Neurological Institute Phoenix AZ

  PRINCIPAL INVESTIGATOR

• Ivan Osorio, MD

  KUMC Kansas City, Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 5, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (2)