Neurofeedback Rehabilitation With FES and VR for PD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with two groups

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BCI group

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).

Group Type EXPERIMENTAL

Brain-Computer Interface with FES and VR

Intervention Type DEVICE

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.

Control group

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.

Group Type SHAM_COMPARATOR

Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback

Intervention Type DEVICE

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.

Interventions

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Brain-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.

Intervention Type DEVICE

Motor 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No