Parkinson Disease
Conditions
Keywords
neuromodulation, TMS, NFB
Brief summary
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.
Interventions
OTHERRepetitive transcranial magnetic stimulation (rTMS)
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.
OTHEREEG guided Neurofeedback (NFB)
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.
Sponsors
National Research Council, Spain
Hospital Beata María Ana
Hospital Universitario de Fuenlabrada
Universidad Francisco de Vitoria
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Idiopathic Parkinsons Disease * Hoehn Yahr Scale I-III * No drug changes in the last 90 days * No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor changes | The day before the first stimulation session and 2 weeks after the first stimulation session | UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation) |
| Neurophysiological cortical changes | The day before the first stimulation session and 2 weeks after the first stimulation session | Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life changes | t2(2 weeks after finishing the protocol) | Changes in PDQ 39 (The 39-Item Parkinson's Disease Questionnaire) score, common range of 0-100 (100 = maximum level of problems). |
| Encephalographic changes | t2(2 weeks after finishing the protocol) | Changes in microstates of electro encephalography (presence of state A, B, C, D and E) |
| Cognitive changes in objective measures of processing speed | t2(2 weeks after finishing the protocol) | Changes in cognitive processing speed using computer based reaction time task |
Outcome results
None listed