Non Invasive Neuromodulation for Patients With Motor Control Disorders

Universidad Francisco de Vitoria

Status

Completed

Conditions

Parkinson Disease

Treatments

Other: EEG guided Neurofeedback (NFB)

Other: Repetitive transcranial magnetic stimulation (rTMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT04017481

NeuroMOD

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

50 participants in 4 patient groups

Repetitive stimulating transcranial stimulation (rTMS)

Experimental group

Description:

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.

Treatment:

Other: Repetitive transcranial magnetic stimulation (rTMS)

EEG guided Neurofeedback (NFB)

Experimental group

Description:

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

Treatment:

Other: EEG guided Neurofeedback (NFB)

rTMS + NFB

Experimental group

Description:

Subjects receive both interventions sequentially