Neurofeedback Rehabilitation With FES and VR for PD
- Conditions
- Parkinson Disease
- Registration Number
- NCT06690931
- Lead Sponsor
- g.tec medical engineering GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Movement Disorders Society - Unified Parkinson's Disease Rating Scale Section III 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.
- Secondary Outcome Measures
Name Time Method 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. This scale assesses: Section I - Non-motor activities of daily living; Section II - Motor activities of daily living; Section IV - Motor complications.
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. 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.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. 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.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. 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.
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. The test is a standardized, quantitative assessment used to measure finger dexterity.
Timed Up & Go 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.
10 Meter Walk 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. 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.
Freezing Of Gait 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. 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.
Trial Locations
- Locations (1)
g.tec medical engineering GmbH
🇦🇹Schiedlberg, Upper Austria, Austria