Non Invasive Neuromodulation for Patients With Motor Control Disorders

Sponsor

Universidad Francisco de Vitoria (Other)

Overall Status

Completed

CT.gov ID

NCT04017481

Collaborator

National Research Council, Spain (Other), Hospital Beata María Ana (Other), Hospital Universitario de Fuenlabrada (Other)

Enrollment

Arms

36.9

Actual Duration (Months)

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

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 NFBEach 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 :

Sep 1, 2016

Actual Primary Completion Date :

Dec 20, 2018

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Motor changes [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)
Motor changes [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)
Neurophysiological cortical changes [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
Neurophysiological cortical changes [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

Quality of life changes [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).
Encephalographic changes [t2(2 weeks after finishing the protocol)]
Changes in microstates of electro encephalography (presence of state A, B, C, D and E)
Cognitive changes in objective measures of processing speed [t2(2 weeks after finishing the protocol)]
Changes in cognitive processing speed using computer based reaction time task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad Francisco de Vitoria
National Research Council, Spain
Hospital Beata María Ana
Hospital Universitario de Fuenlabrada

Investigators

Principal Investigator: Juan Pablo Romero Muñoz, MD PhD, Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universidad Francisco de Vitoria

ClinicalTrials.gov Identifier:

NCT04017481

Other Study ID Numbers:

NeuroMOD

First Posted:

Jul 12, 2019

Last Update Posted:

Nov 20, 2020

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Universidad Francisco de Vitoria

neuromodulation

TMS

NFB

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Nov 20, 2020