Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 18, 2022
February 1, 2022
1.3 years
February 22, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Power spectral density in the frequency of motor imagery from primary motor cortex Baseline
Baseline
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
8 weeks
Study Arms (1)
Transcranial Direct Current Stimulation TDCS
EXPERIMENTALEach 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Parkinson Disease
- Both gender
- Informed consent accepted
- Adults
You may not qualify if:
- Mental diseases
- Injuries in the scalp skin
- Inflammatory tegumentary diseases
- Migraines
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525, Chile
Related Publications (9)
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.
PMID: 32526508BACKGROUNDDagan 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.
PMID: 29436740BACKGROUNDYotnuengnit 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.
PMID: 28650857BACKGROUNDGhai 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.
PMID: 29323122BACKGROUNDBrabenec 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.
PMID: 30337204BACKGROUNDGalvez 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.
PMID: 29297265BACKGROUNDCosta-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.
PMID: 26864140BACKGROUNDGalli 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.
PMID: 22455905BACKGROUNDStuart 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.
PMID: 34505536BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricio E Barría Aburto, MSc.
Corporación de Rehabilitacion Club de Leones Cruz del Sur
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 3, 2022
Study Start
August 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 31, 2022
Last Updated
March 18, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share