Clinical trial NCT04130711: HAptic Neurofeedback Design for Stroke
Official title: Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
neurofeedback
tendon vibration
virtual reality
haptic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Interventional study with minimal risks and constraints, prospective, monocentric.

Detailed description: Many patients with stroke have a severe motor deficit in the upper limb impacting their independence. Electroencephalogram (EEG) Neurofeedback is a re-education technique that improves cerebral plasticity and motor gain in these people during the chronic phase of stroke. The visual feedback usually used tends to diminish the subject's attentional resources, while the proprioceptive feedbacks appear to be more effective on cortical excitability. Vibration feedback inducing movement illusion has been shown to be effective in healthy subjects, but has not been tested in people with stroke.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers : Major (age greater than or equal to 18 years) and under 80 years; Free, informed and written consent signed by the volunteer; Absence of clinical neurological antecedents that can interact with the achievement of the motor task or with the EEG signal.
* Patients after stroke : Major (age greater than or equal to 18 years) and under 80 years;Ischemic or unilateral cerebral hemorrhagic hemorrhagic attack;Stroke dating back more than 6 months (considered as a delay where recovery of the upper limb to wait is less with conventional rehabilitation);Mild to severe upper limb deficiency: FMA-EU score ≤ 60; Free, informed and written consent signed by the patient or a member of his entourage (in the case of a patient able to understand the information and to express his / her consent but presenting motor difficulties leading to an invalid signature).

Exclusion Criteria:

* Healthy Volunteers : major persons subject to legal protection, persons deprived of their liberty
* Patients after stroke : Ischemic or hemorrhagic involvement of posterior fossa (brainstem, cerebellum);Complete motor deficiency of the upper limb (FMA-UE = 0);Epicritic and proprioceptive anesthesia;Understanding difficulties limiting participation in the study;Major persons subject to legal protection, persons deprived of their liberty

Primary outcomes:
measure: Relative Power of Event Related Desynchronization in µ et beta EEG bands of healthy controls and stroke participants
timeFrame: throught study completion, in the 5th week after the onset of the experiment for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Mélanie COGNE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Franc S, Bonan I, Fleury M, Butet S, Barillot C, Lecuyer A, Cogne M. Visual feedback improves movement illusions induced by tendon vibration after chronic stroke. J Neuroeng Rehabil. 2021 Oct 30;18(1):156. doi: 10.1186/s12984-021-00948-7.