earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRennes University Hospital
About this trial
The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke.
Researchers will compare :
Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral ischaemic or haemorrhagic stroke
Adult (18-80 years), both sexes
Stroke < 3 weeks
Upper limb deficit defined by Shoulder Abduction Finger Extension score <5 measured during the 7 days following stroke; i.e., patients predicted to have incomplete recovery
Disqualifiers
Ischemic or hemorrhagic brain stem and/or cerebellum involvement
Multiple strokes
Stroke < 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke
Aphasia with major comprehension impairment
Trial design
Design model
Parallel
Treatments tested in this trial
electroencephalographic neurofeedback
Other interventionThe patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the Neurofeedback group, the patient will receive visual feedback of a virtual hand moving on a computer screen in front of him/her, depending on his/her brain activations. He will also receive haptic feedback (vibrations) in the flexor muscles of his wrist.
SHAM electroencephalographic neurofeedback
Other interventionThe patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the SHAM group, the visual feedback and haptic feedback are randomly generated
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Time frame
28 daysSecondary outcomes
1
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Time frame
28 days2
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Time frame
3 months3
Changes in Action Research Arm Test (ARAT) score
Changes in Action Research Arm Test (ARAT) score
Time frame
28 days4
Changes in Action Research Arm Test (ARAT) score
Changes in Action Research Arm Test (ARAT) score
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rennes University Hospital
Lead sponsor
Fondation de l'Avenir
Collaborator
Source ClinicalTrials.gov