Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase (REMINARY)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
• Intervention / Treatment: Device: Videogames

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Christophe Corvol, MD, PHD; Phone Number: 0033 01 42 16 57 72; Email: jean-christophe.corvol@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hopital Pitie Salpetriere
    • Contact: Jean Christophe CORVOL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback rehabilitation with videogames	Device: Videogames; Videogames

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	total displacement fo the avatar within the game	week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electroencephalography activity	amplitude of the oscillatory activity	week 1, 2, 3, 4, 5 and 6
functional brain MRI	BOLD signal	week 1 and 6

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Jean Christophe Corvol, MD, PHD, Groupe Hospitalier Pitié-Salpêtrière Paris, France, 75013

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: EEG, neurofeedback, fMRI, ALS, surgery, upper limbs
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: K170502J

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No