NCT05698810

Brief Summary

Feasibility study: the examinations carried out as part of this protocol aim to carry out all the acquisitions and simulations of use, necessary for the development of the clinical research protocols to come to Clinatec (in particular, configuration of the equipment, dimension of the examination time and the size of the cohorts etc ...)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
84mo left

Started Mar 2023

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress31%
Mar 2023Mar 2033

First Submitted

Initial submission to the registry

December 13, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2033

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

December 13, 2022

Last Update Submit

August 25, 2025

Conditions

Healthy VolunteersParkinson's Disease PatientsPara/Tetraplegic Patients

Outcome Measures

Primary Outcomes (4)

  • MEG physiological parameters measurements that will be used in future clinical research protocols

    Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

    through study completion, an average of 10 years

  • MRI physiological parameters measurements that will be used in future clinical research

    Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

    through study completion, an average of 10 years

  • EEG physiological parameters measurements that will be used in future clinical research

    Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

    through study completion, an average of 10 years

  • ECG physiological parameters measurements that will be used in future clinical research

    Adequacy of ECG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

    through study completion, an average of 10 years

Secondary Outcomes (4)

  • MEG physiological parameters data collection paradigms

    through study completion, an average of 10 years

  • MRI physiological parameters data collection paradigms

    through study completion, an average of 10 years

  • EEG physiological parameters data collection paradigms

    through study completion, an average of 10 years

  • ECG physiological parameters data collection paradigms

    through study completion, an average of 10 years

Study Arms (3)

Healthy Volunteers

OTHER

tests

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilityOther: CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilityOther: CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilityOther: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Parkinson's Disease patients

OTHER

tests

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilityOther: CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilityOther: CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilityOther: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Para/tetraplegic Patients

OTHER

tests

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilityOther: CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilityOther: CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilityOther: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Interventions

CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilityOTHER

tests

Healthy VolunteersPara/tetraplegic PatientsParkinson's Disease patients
CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilityOTHER

tests

Healthy VolunteersPara/tetraplegic PatientsParkinson's Disease patients
CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilityOTHER

tests

Healthy VolunteersPara/tetraplegic PatientsParkinson's Disease patients
CE marked Medical Device ElectroCardioGraphy (ECG) usabilityOTHER

tests

Healthy VolunteersPara/tetraplegic PatientsParkinson's Disease patients

Eligibility Criteria

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

You may qualify if:

  • Age ⩾ 18 years
  • Affiliated to a social security scheme
  • Free and informed consent signed

You may not qualify if:

  • Subject deprived of liberty by a judicial or administrative decision, or major subject subject to a legal protection measure (guardianship, curatorship and safeguarding of justice) referred to in Articles 1121-6 to 1121-8 of the Public Health Code.
  • Subject who would receive more than 4500 euros in compensation because of his participation in other research involving the human person in the 12 months preceding this study.
  • Pregnant woman, parturient, nursing mother (Article 1121-5 of the Public Health Code)
  • Subject not reachable urgently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinatec Cea/Chuga

Grenoble, 38000, France

RECRUITING

MeSH Terms

Interventions

MagnetoencephalographyMagnetic Resonance Spectroscopyepicatechin gallate

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 26, 2023

Study Start

March 20, 2023

Primary Completion (Estimated)

March 20, 2033

Study Completion (Estimated)

March 20, 2033

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)