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OpenTrials
Completed

NCT Number: NCT04017481

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Collaborators

  • Hospital Beata María Ana
  • Hospital Universitario de Fuenlabrada
  • National Research Council, Spain

Registry information

Official study title

Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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