XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)

NCT04282681 | Withdrawn

• 1 other identifier: LNE-800
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.

Conditions

Epilepsy, Tonic-Clonic

Outcome Measures

Primary Outcomes (1)

• Evaluate accelerometer data and tonic-clonic seizure data

  The study will evaluate accelerometer data and tonic-clonic seizure data that was collected during the patients' EMU admission. The sample size is not based on a statistical power calculation, thus no primary endpoint is defined in the clinical investigation plan.

  1.5 years

Interventions

Accelerometer Live-Streaming Tool OTHER

The only 'intervention' that will take place is the placement of the XLS tool(s) on the upper left chest and/or left wrist of the patient.

Eligibility Criteria

• Age: 4 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been admitted to an EMU for video EEG monitoring (independent of this study) who are expected to have at least one seizure with tonic-clonic convulsive movement.

You may qualify if:

• Four (4) years of age or older.
• Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
• Based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the EMU stay as determined by the investigator.
• Capable of understanding and willing to comply with instructions and study procedures.
• Subject or guardian must be willing and able to complete informed consent/assent.

You may not qualify if:

• Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
• Based on medical history, known to have only absence seizures.
• Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
• Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
• Participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if LivaNova has provided written approval.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (1)

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

MeSH Terms

Conditions

Epilepsy, Tonic-Clonic

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Krisl Vonck

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: March 16, 2020
• Primary Completion: August 28, 2021
• Study Completion: February 28, 2022
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

BE (1)