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Non Invasive Neuromodulation for Patients With Motor Control Disorders

NCT ID: NCT04017481

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Keywords

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neuromodulation TMS NFB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type 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)

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

Group Type EXPERIMENTAL

EEG guided Neurofeedback (NFB)

Intervention Type 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.

rTMS + NFB

Subjects receive both interventions sequentially

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type 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)

Intervention Type 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.

No intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinsons Disease
* Hoehn Yahr Scale I-III
* No drug changes in the last 90 days

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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Council, Spain

OTHER_GOV

Sponsor Role collaborator

Hospital Beata María Ana

OTHER

Sponsor Role collaborator

Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role collaborator

Universidad Francisco de Vitoria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Pablo Romero Muñoz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales

References

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Romero JP, Moreno-Verdu M, Arroyo-Ferrer A, Serrano JI, Herreros-Rodriguez J, Garcia-Caldentey J, Rocon de Lima E, Del Castillo MD. Clinical and neurophysiological effects of bilateral repetitive transcranial magnetic stimulation and EEG-guided neurofeedback in Parkinson's disease: a randomized, four-arm controlled trial. J Neuroeng Rehabil. 2024 Aug 5;21(1):135. doi: 10.1186/s12984-024-01427-5.

Reference Type DERIVED
PMID: 39103947 (View on PubMed)

Other Identifiers

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NeuroMOD

Identifier Type: -

Identifier Source: org_study_id