Non Invasive Neuromodulation for Patients With Motor Control Disorders

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017481
• Other study ID #: NeuroMOD
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria	Hospital Beata María Ana, Madrid, Hospital Universitario de Fuenlabrada, National Research Council, Spain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor changes	UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)	The day before the first stimulation session and 2 weeks after the first stimulation session
Primary	Motor changes	UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)	t2(2 weeks after finishing the protocol)
Primary	Neurophysiological cortical changes	Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response	The day before the first stimulation session and 2 weeks after the first stimulation session
Primary	Neurophysiological cortical changes	Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response	t2(2 weeks after finishing the protocol)
Secondary	Quality of life changes	Changes in PDQ 39 (The 39-Item Parkinson's Disease Questionnaire) score, common range of 0-100 (100 = maximum level of problems).	t2(2 weeks after finishing the protocol)
Secondary	Encephalographic changes	Changes in microstates of electro encephalography (presence of state A, B, C, D and E)	t2(2 weeks after finishing the protocol)
Secondary	Cognitive changes in objective measures of processing speed	Changes in cognitive processing speed using computer based reaction time task	t2(2 weeks after finishing the protocol)