HAptic Neurofeedback Design for Stroke (HANDS)

Rennes University Hospital

Status: Completed

Conditions: Stroke

Treatments: Other: Visual virtual Conditions; Other: Neurofeedback Training Stroke Patients; Other: Standard EEG

Study type: Interventional

Funder types: Other

Identifiers

NCT04130711

35RC19_8866_HANDS

Details and patient eligibility

About

Interventional study with minimal risks and constraints, prospective, monocentric.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

TEST 1: Visual virtual Conditions

Other group

Description:

* 50 subjects (30 healthy volunteers and 20 patients after stroke) * 3 different situations of vibration applications, without EGG neurofeedback session

Treatment:

Other: Visual virtual Conditions

TEST 2: Standard EEG

Other group

Description:

* 20 subjects (healthy volunteers) * 3 separate electroencephalographic recording conditions without Neurofeedback

Treatment:

Other: Standard EEG

TEST 3: Neurofeedback Training Stroke Patients

Other group

Description:

* 26 patients after stroke * 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

Treatment:

Other: Neurofeedback Training Stroke Patients