Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase (NCT03545451) | Clinical Trial Compass
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Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
France30 participantsStarted 2018-10-03
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.