Non Invasive Neuromodulation for Patients With Motor Control Disorders
Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Sep 2016
Typical duration for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedNovember 20, 2020
July 1, 2019
2.3 years
July 2, 2019
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Secondary Outcomes (3)
Quality of life changes
t2(2 weeks after finishing the protocol)
Encephalographic changes
t2(2 weeks after finishing the protocol)
Cognitive changes in objective measures of processing speed
t2(2 weeks after finishing the protocol)
Study Arms (4)
Repetitive stimulating transcranial stimulation (rTMS)
EXPERIMENTALSubjects 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.
EEG guided Neurofeedback (NFB)
EXPERIMENTALSubjects 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
rTMS + NFB
EXPERIMENTALSubjects receive both interventions sequentially
No intervention
NO INTERVENTIONNo interventions, the patient just comes to be evaluated sequentially according to the timing of experimental groups.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinsons Disease
- Hoehn Yahr Scale I-III
- No drug changes in the last 90 days
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Francisco de Vitorialead
- National Research Council, Spaincollaborator
- Hospital Beata María Anacollaborator
- Hospital Universitario de Fuenlabradacollaborator
Related Publications (1)
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.
PMID: 39103947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Pablo Romero Muñoz, MD PhD
Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 12, 2019
Study Start
September 1, 2016
Primary Completion
December 20, 2018
Study Completion
September 30, 2019
Last Updated
November 20, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- six months after the end of the study
- Access Criteria
- Individual anonymized participant data will be available to other researchers under request.
Individual anonymized participant data will be available to other researchers under request.