Neurofeedback Rehabilitation With FES and VR for PD (recoveriX PD)

g.tec medical engineering GmbH

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback; Device: Brain-Computer Interface with FES and VR

Study type: Interventional

Funder types: Industry

Identifiers

NCT06690931

1367/2023

Details and patient eligibility

About

recoveriX PRO system is a Brain-Computer Interface (BCI) device that combines Motor Imagination (MI), with Functional Electrical Stimulation (FES) and Virtual Reality (VR) as feedback devices. The user wears an electroencephalography (EEG) cap that registers the neural activity during the mental practice. This system allows the user to control the feedback devices (FES +VR) with the MI.

The goal of this clinical trial is to know the safety and clinical effectiveness of recoveriX-based treatment for improving motor functions in Parkinson's Disease patients. Researchers will compare the functional results obtained by recoveriX system, to the standard treatment based in FES + VR + MI without monitoring the EEG activity.

The questions to answer are:

1. Will Parkinson's patients who undergo recoveriX therapy significantly improve their motor functions?
2. Is the functional improvement achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
3. Is the recoveriX-based therapy as safe as the standard treatment?

Participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, fatigue, impact of the disease in daily living activities).

Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total).

Patients in the control group receive 6 sessions of FES + VR therapy per week for 4 weeks (24 sessions in total). Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PD
• HY stage between 1 to 3
• Age between 40 - 80 years old
• Ability to walk independently
• Stable medication usage
• Stable neurological condition
• Able to sign the informed consent.
• Able to follow the study protocol.

Exclusion criteria

• Other neurological diseases
• Severe depression
• Uncontrolled diabetes
• Concomitant severe neurologic, cardiopulmonary, or orthopedic disorders
• Debilitating conditions or vision impairment that would impede full participation in the study.
• Unpredictable motor fluctuations
• Pregnant
• Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
• Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
• Under the influence of anesthesia or similar medication.
• With fractures or lesions in the upper and lower extremities.
• Inadequate control of a BCI system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

BCI group

Experimental group

Description:

Patients in the BCI group will receive 6 sessions per week during 4 weeks of BCI training with FES and VR feedback (24 sessions in total).

Treatment:

Device: Brain-Computer Interface with FES and VR

Control group

Sham Comparator group

Description:

Patients in the control group receive 6 sessions of Motor Imagery + FES + VR therapy per week for 4 weeks (24 sessions in total). Patient in the control group will receive the same instructions as the experimental group.

Treatment:

Device: Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback