Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder SurgeryREMINARYNCT03545451
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
A study testing Videogames in people with Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
- What is being tested?
- Videogames
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2018to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common to the 3 populations concerned:
- patients or subjects of both sexes;
- age: 18-70 years;
- ability to give consent in writing;
- Health Insurance.
- SLA:
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- 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.
- Patients after a shoulder trauma: patients with scheduled shoulder surgery. c) Healthy subjects.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital PITIE SALPETRIERE
Paris, 75013
Jean Christophe CORVOL, MD
About this study
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.
- Conditions
- Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
- Being tested
- Videogames
- Keywords
- EEG, neurofeedback, fMRI, ALS, surgery, upper limbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideogamesDevice
Videogames
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback rehabilitation with videogames | Experimental | Neurofeedback rehabilitation with videogames Receives: Device: Videogames |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
total displacement fo the avatar within the game
Measured: week 1
Secondary outcomes (2)
electroencephalography activity
amplitude of the oscillatory activity
Measured: week 1, 2, 3, 4, 5 and 6
functional brain MRI
BOLD signal
Measured: week 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start3 Oct 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe Corvol, MD, PHD, Principal investigator, Groupe Hospitalier Pitié-Salpêtrière Paris, France, 75013
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545451
- Sponsor's protocol ID
- K170502J
- Acronym
- REMINARY
- Status last verified
- May 2018
- First submitted
- 5 Apr 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
- ClinicalTrials.gov ID
- NCT03545451
- Acronym / sponsor ID
- REMINARY / K170502J
- Conditions
- Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery
- Keywords
- EEG, neurofeedback, fMRI, ALS, surgery, upper limbs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback rehabilitation with videogames | Experimental | Device: VideogamesNeurofeedback rehabilitation with videogames |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- patients or subjects of both sexes;
- age: 18-70 years;
- ability to give consent in writing;
- Health Insurance.
- patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideogamesVideogames | Device | Neurofeedback rehabilitation with videogames |
Primary outcome
Performance
Time frame: week 1
total displacement fo the avatar within the game
2 secondary outcomes
electroencephalography activity
Time frame: week 1, 2, 3, 4, 5 and 6
functional brain MRI
Time frame: week 1 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Christophe Corvol, MD, PHD principal investigator
Groupe Hospitalier Pitié-Salpêtrière Paris, France, 75013
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogames in people with Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Christophe Corvol, MD, PHD (01 42 16 57 72 ext. 0033, jean-christophe.corvol@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.