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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Multi-channel Transcranial direct current stimulation
Sponsored by
Corporación de Rehabilitación Club de Leones Cruz del Sur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring transcranial direct current stimulation, auditory stimulation, gait analisys, Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Corporación de Rehabilitación Club de Leones Cruz del SurRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulation TDCS

Arm Description

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.

Outcomes

Primary Outcome Measures

Gait Deviation Index Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Gait Deviation Index Post-Intervention
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system

Secondary Outcome Measures

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).
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).

Full Information

First Posted
February 22, 2022
Last Updated
March 3, 2022
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito, Universidad del Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT05264909
Brief Title
Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
Official Title
Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Collaborators
Colombian School of Engineering Julio Garavito, Universidad del Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
transcranial direct current stimulation, auditory stimulation, gait analisys, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation TDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Multi-channel Transcranial direct current stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Gait Deviation Index Baseline
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Time Frame
Baseline
Title
Gait Deviation Index Post-Intervention
Description
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Power spectral density in the frequency of motor imagery from primary motor cortex Baseline
Description
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).
Time Frame
Baseline
Title
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricio E Barria Aburto, MSc
Phone
+569684585709
Email
pbarria@rehabilitamos.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio E Barría Aburto, MSc.
Organizational Affiliation
Corporación de Rehabilitacion Club de Leones Cruz del Sur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporación de Rehabilitación Club de Leones Cruz del Sur
City
Punta Arenas
State/Province
XII Región
ZIP/Postal Code
6211525
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricio E Barria Aburto, MSc. Eng
Phone
+560612202200
Email
pbarria@rehabilitamos.org
First Name & Middle Initial & Last Name & Degree
Andre I Moris, Eng.
Phone
+560612202200
Email
laboratorios@rehabilitamos.org
First Name & Middle Initial & Last Name & Degree
Patricio Barria Aburto, MSc.
First Name & Middle Initial & Last Name & Degree
Rolando Aguilar Cardenas, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Unquen Mancilla, Lic.
First Name & Middle Initial & Last Name & Degree
Asterio Andrade Gallardo, PhD
First Name & Middle Initial & Last Name & Degree
Angie Pino, Eng
First Name & Middle Initial & Last Name & Degree
Carlos Cifientes, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32526508
Citation
Areas FZDS, Nakamura-Palacios EM, Boening A, Areas GPT, Nascimento LR. Does neuromodulation transcranial direct current stimulation (tDCS) associated with peripheral stimulation through exercise to walk have an impact on falls in people with Parkinson's disease? Med Hypotheses. 2020 Nov;144:109916. doi: 10.1016/j.mehy.2020.109916. Epub 2020 Jun 4.
Results Reference
background
PubMed Identifier
29436740
Citation
Dagan M, Herman T, Harrison R, Zhou J, Giladi N, Ruffini G, Manor B, Hausdorff JM. Multitarget transcranial direct current stimulation for freezing of gait in Parkinson's disease. Mov Disord. 2018 Apr;33(4):642-646. doi: 10.1002/mds.27300. Epub 2018 Feb 13.
Results Reference
background
PubMed Identifier
28650857
Citation
Yotnuengnit P, Bhidayasiri R, Donkhan R, Chaluaysrimuang J, Piravej K. Effects of Transcranial Direct Current Stimulation Plus Physical Therapy on Gait in Patients With Parkinson Disease: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jan;97(1):7-15. doi: 10.1097/PHM.0000000000000783.
Results Reference
background
PubMed Identifier
29323122
Citation
Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5.
Results Reference
background
PubMed Identifier
30337204
Citation
Brabenec L, Klobusiakova P, Barton M, Mekyska J, Galaz Z, Zvoncak V, Kiska T, Mucha J, Smekal Z, Kostalova M, Rektorova I. Non-invasive stimulation of the auditory feedback area for improved articulation in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:187-192. doi: 10.1016/j.parkreldis.2018.10.011. Epub 2018 Oct 10.
Results Reference
background
PubMed Identifier
29297265
Citation
Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
Results Reference
background
PubMed Identifier
26864140
Citation
Costa-Ribeiro A, Maux A, Bosford T, Aoki Y, Castro R, Baltar A, Shirahige L, Moura Filho A, Nitsche MA, Monte-Silva K. Transcranial direct current stimulation associated with gait training in Parkinson's disease: A pilot randomized clinical trial. Dev Neurorehabil. 2017 Apr;20(3):121-128. doi: 10.3109/17518423.2015.1131755. Epub 2016 Feb 10.
Results Reference
background
PubMed Identifier
22455905
Citation
Galli M, Cimolin V, De Pandis MF, Schwartz MH, Albertini G. Use of the Gait Deviation index for the evaluation of patients with Parkinson's disease. J Mot Behav. 2012;44(3):161-7. doi: 10.1080/00222895.2012.664180. Epub 2012 Mar 28.
Results Reference
background
PubMed Identifier
34505536
Citation
Stuart S, Wagner J, Makeig S, Mancini M. Brain Activity Response to Visual Cues for Gait Impairment in Parkinson's Disease: An EEG Study. Neurorehabil Neural Repair. 2021 Nov;35(11):996-1009. doi: 10.1177/15459683211041317. Epub 2021 Sep 10.
Results Reference
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Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients

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