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Non Invasive Neuromodulation for Patients With Motor Control Disorders
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Other: Repetitive transcranial magnetic stimulation (rTMS) Other: EEG guided Neurofeedback (NFB) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| 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 |
| 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. |
| Primary Purpose: | Treatment |
| Official Title: | Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders |
| Actual Study Start Date : | September 1, 2016 |
| Actual Primary Completion Date : | December 20, 2018 |
| Actual Study Completion Date : | September 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Repetitive stimulating transcranial stimulation (rTMS)
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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Other: Repetitive 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.
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Experimental: EEG guided Neurofeedback (NFB)
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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Other: EEG 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.
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Experimental: rTMS + NFB
Subjects receive both interventions sequentially
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Other: Repetitive 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.
Other: EEG 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.
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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.
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- Motor changes [ Time Frame: 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)
- Motor changes [ Time Frame: t2(2 weeks after finishing the protocol) ]UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
- Neurophysiological cortical changes [ Time Frame: 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
- Neurophysiological cortical changes [ Time Frame: t2(2 weeks after finishing the protocol) ]Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
- Quality of life changes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: t2(2 weeks after finishing the protocol) ]Changes in cognitive processing speed using computer based reaction time task
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Idiopathic Parkinsons Disease
- Hoehn Yahr Scale I-III
- No drug changes in the last 90 days
- No exclusion criteria
Exclusion Criteria:
- Dementia (Minimental scale score <25)
- Dependency (modified Rankin scale > 3)
- Pregnancy or pregnancy plans
- Pacemaker
- Implanted metal devices
- cochlear implants
- claustrophobia
- drug infusion pumps
- epilepsy / epileptiform anomalies in electroencephalography (EEG)
- known structural alterations in magnetic resonance imaging (MRI)
- Atypical Parkinsonism
- Previous repetitive transcranial magnetic stimulation (rTMS)
- Severe comorbidity (cancer, severe debilitating diseases, etc.)
| Principal Investigator: | Juan Pablo Romero Muñoz, MD PhD | Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales |
| Tracking Information | |||||||||||||||
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| First Submitted Date ICMJE | July 2, 2019 | ||||||||||||||
| First Posted Date ICMJE | July 12, 2019 | ||||||||||||||
| Last Update Posted Date | November 20, 2020 | ||||||||||||||
| Actual Study Start Date ICMJE | September 1, 2016 | ||||||||||||||
| Actual Primary Completion Date | December 20, 2018 (Final data collection date for primary outcome measure) | ||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
| Change History | |||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Descriptive Information | |||||||||||||||
| Brief Title ICMJE | Non Invasive Neuromodulation for Patients With Motor Control Disorders | ||||||||||||||
| Official Title ICMJE | Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders | ||||||||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment 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 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. Primary Purpose: Treatment
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| Condition ICMJE | Parkinson Disease | ||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||
| Actual Enrollment ICMJE |
50 | ||||||||||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||||||||||
| Actual Study Completion Date ICMJE | September 30, 2019 | ||||||||||||||
| Actual Primary Completion Date | December 20, 2018 (Final data collection date for primary outcome measure) | ||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
| Listed Location Countries ICMJE | Not Provided | ||||||||||||||
| Removed Location Countries | |||||||||||||||
| Administrative Information | |||||||||||||||
| NCT Number ICMJE | NCT04017481 | ||||||||||||||
| Other Study ID Numbers ICMJE | NeuroMOD | ||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Universidad Francisco de Vitoria | ||||||||||||||
| Study Sponsor ICMJE | Universidad Francisco de Vitoria | ||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Universidad Francisco de Vitoria | ||||||||||||||
| Verification Date | July 2019 | ||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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