Neurofeedback Rehabilitation With FES and VR for PD

NCT06690931 | Recruiting

• 1 other identifier: 1367/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Brain-Computer Interface; Neurofeedback; EEG Feedback; Electrical Stimulation Therapy; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III

  Motor examination.

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

Secondary Outcomes (8)

• Movement Disorders Society - Unified Parkinson's Disease Rating Scale - Sections I, II, IV

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

• Parkinson's Disease Questionnaire

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

• Modified Fatigue Impact Scale

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

• Accelerometer Tremor Assessment

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

• 9-Hole Peg Test

  All patients will be evaluated two pre-assessments before (at week 0 and week 1) and two post-assessments (at week 5, and week 7) after the intervention.

Study Arms (2)

BCI group

EXPERIMENTAL

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).

Device: Brain-Computer Interface with FES and VR

Control group

SHAM COMPARATOR

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.

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

Interventions

Brain-Computer Interface with FES and VR 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.

BCI group

Motor imagery with Functional Electrical Stimulation and Virtual Reality feedback 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.

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• g.tec medical engineering GmbH: lead

Study Sites (1)

g.tec medical engineering GmbH

Schiedlberg, Upper Austria, 4521, Austria

RECRUITING

Related Publications (5)

• de Castro-Cros M, Sebastian-Romagosa M, Rodriguez-Serrano J, Opisso E, Ochoa M, Ortner R, Guger C, Tost D. Effects of Gamification in BCI Functional Rehabilitation. Front Neurosci. 2020 Aug 21;14:882. doi: 10.3389/fnins.2020.00882. eCollection 2020.

  PMID: 32973435 BACKGROUND

• Sieghartsleitner S, Sebastian-Romagosa M, Cho W, Grunwald J, Ortner R, Scharinger J, Kamada K, Guger C. Upper extremity training followed by lower extremity training with a brain-computer interface rehabilitation system. Front Neurosci. 2024 Mar 4;18:1346607. doi: 10.3389/fnins.2024.1346607. eCollection 2024.

  PMID: 38500488 BACKGROUND

• Sebastian-Romagosa M, Udina E, Ortner R, Dinares-Ferran J, Cho W, Murovec N, Matencio-Peralba C, Sieghartsleitner S, Allison BZ, Guger C. EEG Biomarkers Related With the Functional State of Stroke Patients. Front Neurosci. 2020 Jul 7;14:582. doi: 10.3389/fnins.2020.00582. eCollection 2020.

  PMID: 32733182 BACKGROUND

• Sebastian-Romagosa M, Cho W, Ortner R, Murovec N, Von Oertzen T, Kamada K, Allison BZ, Guger C. Brain Computer Interface Treatment for Motor Rehabilitation of Upper Extremity of Stroke Patients-A Feasibility Study. Front Neurosci. 2020 Oct 21;14:591435. doi: 10.3389/fnins.2020.591435. eCollection 2020.

  PMID: 33192277 BACKGROUND

• Sebastian-Romagosa M, Cho W, Ortner R, Sieghartsleitner S, Von Oertzen TJ, Kamada K, Laureys S, Allison BZ, Guger C. Brain-computer interface treatment for gait rehabilitation in stroke patients. Front Neurosci. 2023 Oct 18;17:1256077. doi: 10.3389/fnins.2023.1256077. eCollection 2023.

  PMID: 37920297 BACKGROUND

Related Links

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MeSH Terms

Conditions

Parkinson Disease

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Rupert Ortner, PhD

CONTACT

+43725122240; ortner@gtec.at

Marc Sebastián-Romagosa, PhD

CONTACT

+34936764579; sebastian@gtec.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)