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

Non Invasive Neuromodulation for Patients With Motor Control Disorders

Sponsors

Lead sponsor: Universidad Francisco de Vitoria

Collaborator: National Research Council, Spain
Hospital Beata María Ana, Madrid
Hospital Universitario de Fuenlabrada

Source 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.

Overall Status Active, not recruiting
Start Date September 1, 2016
Completion Date September 30, 2019
Primary Completion Date December 20, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Motor changes The day before the first stimulation session and 2 weeks after the first stimulation session
Motor changes t2(2 weeks after finishing the protocol)
Neurophysiological cortical changes The day before the first stimulation session and 2 weeks after the first stimulation session
Neurophysiological cortical changes t2(2 weeks after finishing the protocol)
Secondary Outcome
Measure Time Frame
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)
Enrollment 50
Condition
Intervention

Intervention type: Other

Intervention name: Repetitive transcranial magnetic stimulation (rTMS)

Description: 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.

Intervention type: Other

Intervention name: EEG guided Neurofeedback (NFB)

Description: 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:

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.)

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Juan Pablo Romero Muñoz, MD PhD Principal Investigator Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Repetitive stimulating transcranial stimulation (rTMS)

Arm group type: Experimental

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.

Arm group label: EEG guided Neurofeedback (NFB)

Arm group type: Experimental

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

Arm group label: rTMS + NFB

Arm group type: Experimental

Description: Subjects receive both interventions sequentially

Arm group label: No intervention

Arm group type: No Intervention

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

Patient Data Yes
Study Design Info

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

Primary purpose: Treatment

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.

Source: ClinicalTrials.gov