RecruitingNot ApplicableNCT06690931

Neurofeedback Rehabilitation With FES and VR for PD

Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities

Sponsor

g.tec medical engineering GmbH

Enrollment

30 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria8

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 Criteria12

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.

Interventions

DEVICEBrain-Computer Interface with FES and VR

The intervention utilizes the recoveriX PRO system. This is a neurofeedback therapy device that combines Brain-Computer Interface based motor imagery, functional electrical stimulation (FES), and virtual reality (VR). This approach enables participants to engage in motor imagery exercises while receiving real-time feedback based on neural signals. Participants will complete a total of 24 recoveriX sessions, scheduled at 6 sessions per week, with each session lasting 1 hour.

DEVICEMotor imagery with Functional Electrical Stimulation and Virtual Reality feedback

The participants will train the Motor Imagination (MI) combined with Functional Electrical Stimulation (FES) and Virtual Reality (VR) feedback. Feedback provided to the patients will not be linked to the neural signals. The amount of stimulation delivered by the feedback devices (FES and VR) will be similar to the experimental group.