Non Invasive Neuromodulation for Patients With Motor Control Disorders

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Repetitive transcranial magnetic stimulation (rTMS); Other: EEG guided Neurofeedback (NFB)

• Registration Number: NCT04017481
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2018-12-20
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Completion: 2019-09-30
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Repetitive stimulating transcranial stimulation (rTMS)	Repetitive transcranial magnetic 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.
rTMS + NFB	EEG guided Neurofeedback (NFB)	Subjects receive both interventions sequentially
EEG guided Neurofeedback (NFB)	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
rTMS + NFB	Repetitive transcranial magnetic stimulation (rTMS)	Subjects receive both interventions sequentially

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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).
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
Encephalographic changes	t2(2 weeks after finishing the protocol)	Changes in microstates of electro encephalography (presence of state A, B, C, D and E)