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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorders Society - Unified Parkinson's Disease Rating Scale - Sections I, II, IV | This scale assesses: Section I - Non-motor activities of daily living; Section II - Motor activities of daily living; Section IV - Motor complications. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rupert Ortner, PhD | Contact | +43725122240 | ortner@gtec.at | |
| Marc Sebastián-Romagosa, PhD | Contact | +34936764579 | sebastian@gtec.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| g.tec medical engineering GmbH | Recruiting | Schiedlberg | Upper Austria | 4521 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32973435 | Background | 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. | |
| 38500488 | 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. |
| Label | URL |
|---|---|
| Contact | View source |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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Randomized controlled trial with two groups
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| 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. |
|
| Parkinson's Disease Questionnaire | The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and wellbeing. This scale has 39 items, each item has a 5-point ordinal scoring system. The scale ranges from 0 to 156, where low values are related with better quality of life (QoL) and high values to low QoL. | 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 | The MFIS is a modified form of the Fatigue Impact Scale (Fisk et al. 1994) based on items derived from interviews with PD patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0='Never' to 4='Almost always' their agreement with 21 statements. Total scale (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue. | 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 | The tremor will be assessed using a small accelerometer placed at the dorsal side of the wrist and above the medial tibial malleolus. Based on the changes in accelerometry a score is generated quantifying the amount of tremor during rest and movement. | 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 | The test is a standardized, quantitative assessment used to measure finger dexterity. | 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. |
| Timed Up & Go | This test measures the time it takes patients to get up from a chair, walk 3 metres, turn around, walk 3 metres back and sit down again. | 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. |
| 10 Meter Walk Test | The 10MWT assesses walking speed in meters per second over a short distance. Individuals walk 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. | 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. |
| Freezing Of Gait Questionnaire | The FOGQ assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). Currently, FOGQ is the only validated tool available to subjectively assess FOG. The scale has 6 items, 4 of these items are related to assess FOG severity and 2 are oriented to assess gait. Each item is assessed from 0 to 4 points. Total score ranges from 0 to 24, and higher scores correspond to more severe FOG. | 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. |
| 32733182 | 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. |
| 33192277 | 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. |
| 37920297 | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |