Epilepsy Motion Sensing

Medtronic

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Industry

Identifiers

NCT01850498

1663

Details and patient eligibility

About

Evaluate patient motion during seizures.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
• Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
• Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
• Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
• Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
• Male or non-pregnant female
• English speaking

Exclusion criteria

• Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
• Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
• Have a movement disorder that may affect GT3X+ recordings

Trial design

19 participants in 2 patient groups

Partial seizures

Description:

Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior

Generalized seizures

Description:

Primarily generalized seizures (in patients with either primary \[idiopathic\] or secondary \[symptomatic\] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.