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

March 3, 2022 updated by: Corporación de Rehabilitación Club de Leones Cruz del Sur

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • XII Región
      • Punta Arenas, XII Región, Chile, 6211525
        • Recruiting
        • Corporación de Rehabilitación Club de Leones Cruz del Sur
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricio Barria Aburto, MSc.
        • Sub-Investigator:
          • Rolando Aguilar Cardenas, PhD
        • Sub-Investigator:
          • Daniel Unquen Mancilla, Lic.
        • Sub-Investigator:
          • Asterio Andrade Gallardo, PhD
        • Sub-Investigator:
          • Angie Pino, Eng
        • Principal Investigator:
          • Carlos Cifientes, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson Disease
  • Both gender
  • Informed consent accepted
  • Adults

Exclusion Criteria:

  • Mental diseases
  • Injuries in the scalp skin
  • Inflammatory tegumentary diseases
  • Migraines
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial Direct Current Stimulation TDCS

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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Collaborators

Universidad del Rosario
Colombian School of Engineering Julio Garavito

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorporacionRCLCS0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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