Parkinson Disease Clinical Trial
Official title:
Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
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.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Parkinson Disease - Both gender - Informed consent accepted - Adults Exclusion Criteria: - Mental diseases - Injuries in the scalp skin - Inflammatory tegumentary diseases - Migraines - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Chile | Corporación de Rehabilitación Club de Leones Cruz del Sur | Punta Arenas | XII Región |
Lead Sponsor | Collaborator |
---|---|
Corporación de Rehabilitación Club de Leones Cruz del Sur | Colombian School of Engineering Julio Garavito, Universidad del Rosario |
Chile,
Arêas FZDS, Nakamura-Palacios EM, Boening A, Arêas 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Gálvez 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. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gait Deviation Index Baseline | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system | Baseline | |
Primary | 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 | 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 | |
Secondary | 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 |
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