HAptic Neurofeedback Design for Stroke

Not Applicable

Completed

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

• Registration Number: NCT04130711
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Study Start: 2019-10-23
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEST 1: Visual virtual Conditions	Visual virtual Conditions	* 50 subjects (30 healthy volunteers and 20 patients after stroke) * 3 different situations of vibration applications, without EGG neurofeedback session
TEST 2: Standard EEG	Standard EEG	* 20 subjects (healthy volunteers) * 3 separate electroencephalographic recording conditions without Neurofeedback
TEST 3: Neurofeedback Training Stroke Patients	Neurofeedback Training Stroke Patients	* 26 patients after stroke * 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

Primary Outcome Measures

Name	Time	Method
Relative Power of Event Related Desynchronization in µ et beta EEG bands of healthy controls and stroke participants	throught study completion, in the 5th week after the onset of the experiment for each participant	The relative increase of Event Related Desynchronization (ERD) relative power sensorimotor rhythms (µ et beta bands) in EEG during the last session of NeuroFeedBack in the motor cortex, between motor imagery and rest, measured in microvolt

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France