Clinical trial NCT04017481: Non Invasive Neuromodulation for Patients With Motor Control Disorders
Official title: Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: neuromodulation
TMS
NFB
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
Collaborators: name: National Research Council, Spain
name: Hospital Beata María Ana
name: Hospital Universitario de Fuenlabrada
First posted: 2019-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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
Primary purpose: TREATMENT

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.


Eligibility 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.)

Primary outcomes:
measure: Motor changes
timeFrame: The day before the first stimulation session and 2 weeks after the first stimulation session
measure: Motor changes
timeFrame: t2(2 weeks after finishing the protocol)
measure: Neurophysiological cortical changes
timeFrame: The day before the first stimulation session and 2 weeks after the first stimulation session
measure: Neurophysiological cortical changes
timeFrame: t2(2 weeks after finishing the protocol)
Secondary outcomes:
measure: Quality of life changes
timeFrame: t2(2 weeks after finishing the protocol)
measure: Encephalographic changes
timeFrame: t2(2 weeks after finishing the protocol)
measure: Cognitive changes in objective measures of processing speed
timeFrame: t2(2 weeks after finishing the protocol)
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
name: Juan Pablo Romero Muñoz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: