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| Name | Class |
|---|---|
| National Research Council, Spain | OTHER_GOV |
| Hospital Beata MarÃa Ana | OTHER |
| Hospital Universitario de Fuenlabrada | OTHER |
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Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of life.
This project NeuroMOD (neuromodulation for patients with disorders of motor control) proposes the development of a neuromodulation-based platform for the rehabilitation and restoration of motor and cognitive functions of patients suffering from Parkinson's disease (PD). Our project will focus on the application of a novel neurorehabilitation strategy, its functional and clinical validation, and on the evaluation of the impact of the use of the technologies involved in the musculoskeletal and the nervous system as well as user behavior.
Parkinson's disease was selected as target pathology since it represents a paradigm of motor disorder diseases.
Parkinson's disease affects adults and has a very high prevalence and a very high functional impact.
In order to achieve this objective, we have defined the following research areas:
Subproject 1. NeuroMOD: development of a neuromodulation platform composed by a TMS system, and an EMG (electromyography) and EEG (electroencephalography) system in combination with a system of virtual reality based on immersive glasses.
Subproject 2. NeuroMOD-PD: development of therapies and evaluation of clinical evidence and motor and cognitive impact of NeuroMOD in the rehabilitation of patients suffering from Parkinson's disease impact.
Subproject 3. NeuroMOD-Image: development of neuroimaging techniques to investigate the brain areas affected by the proposed therapies and temporary terms that neural plasticity is induced and evolves in Parkinson´s Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive stimulating transcranial stimulation (rTMS) | Experimental | Subjects receive 8 sessions M1 Neuromodulation using rTMS according to the protocol ( 80% resting motor threshold, 10 Hertz; 1000 pulses; 25 trains de 4 seconds con 25 seconds intertrain. |
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| EEG guided Neurofeedback (NFB) | Experimental | Subjects receive 8 sessions M1 EEG guided NFB with virtual reality goggles in order to modify the beta rhythm. The sessions have a duration of 20min |
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| rTMS + NFB | Experimental | Subjects receive both interventions sequentially |
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| No intervention | No Intervention | No interventions, the patient just comes to be evaluated sequentially according to the timing of experimental groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Other | The intervention intends to change the cortical plasticity in specific cortical areas. rTMS is a non-invasive exogenous neuromodulation technique that uses repetitive magnetic pulses administered in a specific area of the head in order to influence the connectivity of the underlying brain area. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor changes | UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation) | The day before the first stimulation session and 2 weeks after the first stimulation session |
| Motor changes | UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation) | t2(2 weeks after finishing the protocol) |
| Neurophysiological cortical changes | Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response | The day before the first stimulation session and 2 weeks after the first stimulation session |
| Neurophysiological cortical changes | Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response | t2(2 weeks after finishing the protocol) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life changes | Changes in PDQ 39 (The 39-Item Parkinson's Disease Questionnaire) score, common range of 0-100 (100 = maximum level of problems). | t2(2 weeks after finishing the protocol) |
| Encephalographic changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pablo Romero Muñoz, MD PhD | Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39103947 | Derived | Romero JP, Moreno-Verdu M, Arroyo-Ferrer A, Serrano JI, Herreros-Rodriguez J, Garcia-Caldentey J, Rocon de Lima E, Del Castillo MD. Clinical and neurophysiological effects of bilateral repetitive transcranial magnetic stimulation and EEG-guided neurofeedback in Parkinson's disease: a randomized, four-arm controlled trial. J Neuroeng Rehabil. 2024 Aug 5;21(1):135. doi: 10.1186/s12984-024-01427-5. |
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Individual anonymized participant data will be available to other researchers under request.
six months after the end of the study
Individual anonymized participant data will be available to other researchers under request.
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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 |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Each study participant is assigned to one of the arms. Four intervention groups are defined as rTMS only, NFB only, both TMS and NFB, or neither TMS or NFB
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Final outcomes evaluators are blinded. Clinical evaluation is performed using videotaped neurological examination. Neurophysiological evaluation is done with the raw data recorded during the sessions.
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| EEG guided Neurofeedback (NFB) | Other | The intervention intends to change the cortical plasticity in specific cortical areas. The NFB is a non-invasive endogenous technique that seeks the self-regulation of cortical activity through the information represented in a videogame which is used to interact with the subject. |
|
Changes in microstates of electro encephalography (presence of state A, B, C, D and E)
| t2(2 weeks after finishing the protocol) |
| Cognitive changes in objective measures of processing speed | Changes in cognitive processing speed using computer based reaction time task | t2(2 weeks after finishing the protocol) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |