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

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ClinicalTrials.gov Identifier: NCT03545451
Recruitment Status : Not yet recruiting
First Posted : June 4, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery Device: Videogames Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Neurofeedback rehabilitation with videogames
Neurofeedback rehabilitation with videogames
Device: Videogames
Videogames




Primary Outcome Measures :
  1. Performance [ Time Frame: week 1 ]
    total displacement fo the avatar within the game


Secondary Outcome Measures :
  1. electroencephalography activity [ Time Frame: week 1, 2, 3, 4, 5 and 6 ]
    amplitude of the oscillatory activity

  2. functional brain MRI [ Time Frame: week 1 and 6 ]
    BOLD signal



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545451


Contacts
Contact: Jean Christophe Corvol, MD, PHD 01 42 16 57 72 ext 0033 jean-christophe.corvol@aphp.fr

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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03545451     History of Changes
Other Study ID Numbers: K170502J
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
EEG, neurofeedback, fMRI, ALS, surgery, upper limbs

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases