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Non Invasive Neuromodulation for Patients With Motor Control Disorders

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ClinicalTrials.gov Identifier: NCT04017481
Recruitment Status : Active, not recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Research Council, Spain
Hospital Beata María Ana, Madrid
Hospital Universitario de Fuenlabrada
Information provided by (Responsible Party):
Universidad Francisco de Vitoria

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Repetitive transcranial magnetic stimulation (rTMS) Other: EEG guided Neurofeedback (NFB) Not Applicable

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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
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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
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.

Experimental: rTMS + NFB
Subjects receive both interventions sequentially
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.

No Intervention: No intervention
No interventions, the patient just comes to be evaluated sequentially according to the timing of experimental groups.



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017481


Sponsors and Collaborators
Universidad Francisco de Vitoria
National Research Council, Spain
Hospital Beata María Ana, Madrid
Hospital Universitario de Fuenlabrada
Investigators
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Principal Investigator: Juan Pablo Romero Muñoz, MD PhD Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales

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Responsible Party: Universidad Francisco de Vitoria
ClinicalTrials.gov Identifier: NCT04017481     History of Changes
Other Study ID Numbers: NeuroMOD
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual anonymized participant data will be available to other researchers under request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Universidad Francisco de Vitoria:
neuromodulation
TMS
NFB

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases