NCT02389257

Brief Summary

Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

January 8, 2015

Last Update Submit

September 27, 2017

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse EventsMagnetic brain or cardiac activity

    Measure of Safety and Tolerability

    1 year

Secondary Outcomes (1)

  • Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record)

    1 hour

Study Arms (2)

MINIMAG / MEG

EXPERIMENTAL

Cerebral magnetic fields

Device: MINIMAG / MEG

MINIMAG / ECG

EXPERIMENTAL

Cardiac magnetic fields

Device: MINIMAG / ECG

Interventions

MINIMAG / MEGDEVICE
MINIMAG / MEG
MINIMAG / ECGDEVICE
MINIMAG / ECG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more or equal than 18 years old
  • patient affiliated to social security or similarly regime
  • informed consent form signed
  • without cardiac, neurologic, psychiatric or metabolic medical history.

You may not qualify if:

  • Pregnant women and lactating mothers
  • Ward of court or under guardianship
  • Adult unable to express their consent
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent
  • Person under legal protection
  • Person with any implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CLINATEC

Grenoble, 38000, France

Location

MeSH Terms

Interventions

MagnetoencephalographyElectrocardiography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

March 17, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

FR(1)