Clinical trial NCT06690931: Neurofeedback Rehabilitation With FES and VR for PD
Official title: Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Brain-Computer Interface
Neurofeedback
EEG Feedback
Electrical Stimulation Therapy
Virtual reality
Lead sponsor: g.tec medical engineering GmbH
Sponsor class: INDUSTRY
First posted: 2024-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups
Primary purpose: TREATMENT

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. 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 criteria: 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.

Primary outcomes:
measure: Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III
timeFrame: 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:
measure: Movement Disorders Society - Unified Parkinson's Disease Rating Scale - Sections I, II, IV
timeFrame: 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.
measure: Parkinson's Disease Questionnaire
timeFrame: 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.
measure: Modified Fatigue Impact Scale
timeFrame: 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.
measure: Accelerometer Tremor Assessment
timeFrame: 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.
measure: 9-Hole Peg Test
timeFrame: 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.
measure: Timed Up & Go
timeFrame: 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.
measure: 10 Meter Walk Test
timeFrame: 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.
measure: Freezing Of Gait Questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Schiedlberg
country: Austria
facility: g.tec medical engineering GmbH
state: Upper Austria
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.