Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
NCT06690931

Neurofeedback Rehabilitation With FES and VR for PD

Led by g.tec medical engineering GmbH · Updated on 2025-05-09

30

Participants Needed

1

Research Sites

137 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Neurofeedback Rehabilitation With FES and VR for PD

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Parkinson's Disease
  • Hoehn and Yahr (HY) stage between 1 and 3
  • Age between 40 and 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
Not Eligible

You will not qualify if you...

  • Other neurological diseases
  • Severe depression
  • Uncontrolled diabetes
  • Severe neurologic, cardiopulmonary, or orthopedic disorders
  • Debilitating conditions or vision impairment that impede participation
  • Unpredictable motor fluctuations
  • Pregnant
  • Active or passive implanted medical devices such as pacemakers incompatible with FES
  • Implanted metallic fragments in upper or lower extremities limiting FES use
  • Under the influence of anesthesia or similar medications
  • Fractures or lesions in upper or lower extremities
  • Inadequate control of a Brain-Computer Interface system

AI-Screening

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Trial Site Locations

Total: 1 location

1

g.tec medical engineering GmbH

Schiedlberg, Upper Austria, Austria, 4521

Actively Recruiting

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Research Team

R

Rupert Ortner, PhD

CONTACT

M

Marc Sebastián-Romagosa, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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