Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments. Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed. Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. This protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.

Detailed Description
-----------------
According to the World Health Organization (WHO), Parkinson's disease affects 1 in 100 people over the age of 60. Currently, there are about 7 million people with this disease in the world and the WHO predicts that by 2030 they will reach more than 12 million. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia. This disease usually affects people over 60 years of age, whose symptoms worsen as the disease progresses and in many cases the ability to function in everyday situations is greatly affected. Due to decreased levels of dopamine, motor symptoms such as tremor, stiffness, slowness of movement, postural instability and other non-motor symptoms such as depression, hallucinations, insomnia and dysfunction of the autonomous organic systems, for example, digestion and blood pressure, as well as alteration in the expression of emotions. Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments. Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. During tDCS, most people feel a slight tingling, pricking, itching or warmth, however, these sensations are not painful and disappear when the stimulation is stopped. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed. Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Sounds, mainly rhythm, have also been shown to improve gait characteristics (speed, time and cadence of passage) and eliminate frozen gait, characteristic in this type of population. Sound strategies such as Binaural Beats (BBs) improve the ability of upper and lower limb movements in PD patients. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. In accordance with the above, this protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.

Official Title
-----------------
Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Multi-channel Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson Disease Both gender Informed consent accepted Adults Exclusion Criteria: Mental diseases Injuries in the scalp skin Inflammatory tegumentary diseases Migraines Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Direct Current Stimulation TDCS<br>Each subject will receive transcranial electrical stimulation at primary motor located in Cz based on the EEG 10-20 international system. The program include 18 sessions with a frequency of 3 times per week during 6 weeks. Therefore, during tDCS sessions, subjects will receive stimulation for 15 minutes with a current of 1.5 milliamp using 7x5 cm electrodes. During the stimulation, the patient must simultaneously perform gait training for 30 minutes where the speed of each step is guided by the frequency of biaural rhythms and beats, constantly heard through hearing aids. Additionally, the length of the passage will be indicated by white stripes (50 cm long and 5 cm wide), placed perpendicular along a walkway of 6.5 m. Thus, each session will be monitored on safety aspects of the subjects with emphasis on skin problems and other possible side effects of tDCS. | Device: Multi-channel Transcranial direct current stimulation<br>* A medical grade tDCS device will be use in this study (Star Stim TES, Neuroelectrics, Spain). The device is a wireless multi-channel transcranial direct current stimulator that incorporates an 8-channel headcap for stimulation through gel electrodes or classic sponge electrodes. The device is integrated with a user interface for the configuration and monitoring of the stimulus parameters and a fast multifocal simulation of the tDCS electric field using an advanced brain model<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Deviation Index Baseline | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system | Baseline | 
| Gait Deviation Index Post-Intervention | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power spectral density in the frequency of motor imagery from primary motor cortex Baseline | continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz). | Baseline | 
| Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention | continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz). | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial direct current stimulation, auditory stimulation, gait analisys, Parkinson Disease