NCT Number: NCT06690931
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Schiedlberg, Upper Austria, 4521, Austria
Location status: Recruiting
Christoph Guger, PhD
CONTACT
Christoph Guger, PhD
SUB_INVESTIGATOR
Marc Sebastián-Romagosa, PhD
SUB_INVESTIGATOR
Michael Guger, MD
PRINCIPAL_INVESTIGATOR
Rupert Ortner, PhD
CONTACT
Rupert Ortner, PhD
SUB_INVESTIGATOR
Sebastian Sieghartsleitner
SUB_INVESTIGATOR
Woosang Cho, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Motor examination.
Time frame: 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.
This scale assesses: Section I - Non-motor activities of daily living; Section II - Motor activities of daily living; Section IV - Motor complications.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
The test is a standardized, quantitative assessment used to measure finger dexterity.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Contact information is provided by the study sponsor or research team.
Marc Sebastián-Romagosa, PhD
CONTACT
Rupert Ortner, PhD
CONTACT
g.tec medical engineering GmbH
Industry
Parkinson's Disease Rehabilitation Using Neurofeedback With Functional Electrical Stimulation and Virtual Reality Feedback for Lower Extremities
Acronym: recoveriX PD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07207122
Basal Ganglia Diseases, Brain Diseases
Santa Monica, California, United States
View Trial DetailsNCT06680830
Basal Ganglia Diseases, Brain Diseases
Sun City, Arizona, United States
View Trial DetailsNCT07323121
Basal Ganglia Diseases, Brain Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT04477785
Anosmia, Basal Ganglia Diseases
Birmingham, Alabama, United States
View Trial Details