Back to resultsNeurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase (REMINARY)
Primary Purpose
Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Videogames
Sponsored by
About this trial
This is an interventional other trial for Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery focused on measuring EEG, neurofeedback, fMRI, ALS, surgery, upper limbs
Eligibility Criteria
Inclusion Criteria:
Common to the 3 populations concerned:
- patients or subjects of both sexes;
- age: 18-70 years;
- ability to give consent in writing;
Health Insurance.
a) SLA:
- patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis;
Percentage of forced vital capacity (FVC) ≥ 65% of the predicted value for age, gender and size.
b) Patients after a shoulder trauma: patients with scheduled shoulder surgery. c) Healthy subjects.
Exclusion Criteria:
- Dementia (MMSE score <24/30)
- Pregnancy or patient not having effective contraception.
- Other neurological, psychiatric or orthopedic disease leading to a motor handicap or an inability to correctly realize the experimental paradigm: interfering with the evaluation of the movements of the upper limb, incapacity to realize the mental imagery of the movement.
- Visual impairment resulting in an inability to properly view the computer screen.
- History of epilepsy or active epilepsy.
- Contraindication to MRI: cardiac or neuronal simulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, claustrophobia
- Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights and liberty
- Subject in the exclusion period of another interventional research or participating in any other interventional research or therapeutic trial
- Presence of another severe progressive pathology
Sites / Locations
- Hopital PITIE SALPETRIERERecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurofeedback rehabilitation with videogames
Arm Description
Neurofeedback rehabilitation with videogames
Outcomes
Primary Outcome Measures
Performance
total displacement fo the avatar within the game
Secondary Outcome Measures
electroencephalography activity
amplitude of the oscillatory activity
functional brain MRI
BOLD signal
Full Information
NCT ID
NCT03545451
First Posted
April 5, 2018
Last Updated
October 10, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03545451
Brief Title
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
Acronym
REMINARY
Official Title
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
As the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, INSEE projections). The possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. The possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. In this research project, we will use the principle of neurofeedback rehabilitation (EEG) based on motor imaging with a brain-computer interface. Feedback will consist of therapeutic video games.Here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
Keywords
EEG, neurofeedback, fMRI, ALS, surgery, upper limbs
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback rehabilitation with videogames
Arm Type
Experimental
Arm Description
Neurofeedback rehabilitation with videogames
Intervention Type
Device
Intervention Name(s)
Videogames
Intervention Description
Videogames
Primary Outcome Measure Information:
Title
Performance
Description
total displacement fo the avatar within the game
Time Frame
week 1
Secondary Outcome Measure Information:
Title
electroencephalography activity
Description
amplitude of the oscillatory activity
Time Frame
week 1, 2, 3, 4, 5 and 6
Title
functional brain MRI
Description
BOLD signal
Time Frame
week 1 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Common to the 3 populations concerned:
patients or subjects of both sexes;
age: 18-70 years;
ability to give consent in writing;
Health Insurance.
a) SLA:
patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis;
Percentage of forced vital capacity (FVC) ≥ 65% of the predicted value for age, gender and size.
b) Patients after a shoulder trauma: patients with scheduled shoulder surgery. c) Healthy subjects.
Exclusion Criteria:
Dementia (MMSE score <24/30)
Pregnancy or patient not having effective contraception.
Other neurological, psychiatric or orthopedic disease leading to a motor handicap or an inability to correctly realize the experimental paradigm: interfering with the evaluation of the movements of the upper limb, incapacity to realize the mental imagery of the movement.
Visual impairment resulting in an inability to properly view the computer screen.
History of epilepsy or active epilepsy.
Contraindication to MRI: cardiac or neuronal simulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, claustrophobia
Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights and liberty
Subject in the exclusion period of another interventional research or participating in any other interventional research or therapeutic trial
Presence of another severe progressive pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Christophe Corvol, MD, PHD
Phone
01 42 16 57 72
Ext
0033
Email
jean-christophe.corvol@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Christophe Corvol, MD, PHD
Organizational Affiliation
Groupe Hospitalier Pitié-Salpêtrière Paris, France, 75013
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital PITIE SALPETRIERE
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Christophe CORVOL, MD
12. IPD Sharing Statement
Learn more about this trial
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
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