Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403788
• Other study ID #: CorporacionRCLCS0007
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: Corporación de Rehabilitación Club de Leones Cruz del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Description:

Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease (PD) have been proposed, such as physical activity performance and developing games to exercise the mind. However, few studies illustrate the incidence of these therapies in neuronal activity. This work aims to study the feasibility of a virtual reality-based program oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was divided in intervention with the program, acquisition of signals, data processing and results analysis. The alpha and beta bands power behaviour were determined by evaluating the electroencephalography (EEG) signals obtained during the execution of control tests and games of the "Hand Physics Lab" Software, from which five games related to attention, planning, sequencing, concentration, and coordination, were taken. The study highlights implementing new technologies to rehabilitate people with neurodegenerative diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 31, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Parkinson Disease (Neurologist diagnosed)
• Both gender
• Informed consent accepted
• Adults
• Stage 2 and 3 in the Hoehn Yahr scale

Exclusion Criteria:

• Mental diseases
• Migraines
• Pregnancy

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Intervention with virtual reality
VR intervention with OCULUS QUEST2 (OCULUS VR, USA) consiste on a VR helmet positioned over subject head. The software consisted of a 3D environment with exercises of upper limbs and visual feedback for the treatment of cognitive and motor dysfunction. The therapist have real-time access to the activities in the 3D environment vby real-time video transmission of the helmet activity. The program include a single session. Each session is monitored on safety aspects of the subjects with emphasis on possible side effects of virtual reality.

Locations

Country	Name	City	State
Chile	Corporación de Rehabilitación Club de Leones Cruz del Sur	Punta Arenas	XII Región

Sponsors (3)

Lead Sponsor	Collaborator
Corporación de Rehabilitación Club de Leones Cruz del Sur	Colombian School of Engineering Julio Garavito, Universidad del Rosario

Country where clinical trial is conducted

Chile, 

References & Publications (19)

Abe Y, Kachi T, Kato T, Arahata Y, Yamada T, Washimi Y, Iwai K, Ito K, Yanagisawa N, Sobue G. Occipital hypoperfusion in Parkinson's disease without dementia: correlation to impaired cortical visual processing. J Neurol Neurosurg Psychiatry. 2003 Apr;74(4):419-22. — View Citation

Alarcon G, Guy CN, Binnie CD. A simple algorithm for a digital three-pole Butterworth filter of arbitrary cut-off frequency: application to digital electroencephalography. J Neurosci Methods. 2000 Dec 15;104(1):35-44. — View Citation

Armstrong RA. Visual symptoms in Parkinson's disease. Parkinsons Dis. 2011;2011:908306. doi: 10.4061/2011/908306. Epub 2011 May 25. — View Citation

Botha H, Carr J. Attention and visual dysfunction in Parkinson's disease. Parkinsonism Relat Disord. 2012 Jul;18(6):742-7. doi: 10.1016/j.parkreldis.2012.03.004. Epub 2012 Apr 11. Review. — View Citation

Bronte-Stewart H, Barberini C, Koop MM, Hill BC, Henderson JM, Wingeier B. The STN beta-band profile in Parkinson's disease is stationary and shows prolonged attenuation after deep brain stimulation. Exp Neurol. 2009 Jan;215(1):20-8. doi: 10.1016/j.expneurol.2008.09.008. Epub 2008 Sep 27. — View Citation

Cikajlo I, Peterlin Potisk K. Advantages of using 3D virtual reality based training in persons with Parkinson's disease: a parallel study. J Neuroeng Rehabil. 2019 Oct 17;16(1):119. doi: 10.1186/s12984-019-0601-1. — View Citation

Duchesne C, Lungu O, Nadeau A, Robillard ME, Boré A, Bobeuf F, Lafontaine AL, Gheysen F, Bherer L, Doyon J. Enhancing both motor and cognitive functioning in Parkinson's disease: Aerobic exercise as a rehabilitative intervention. Brain Cogn. 2015 Oct;99:68-77. doi: 10.1016/j.bandc.2015.07.005. Epub 2015 Aug 7. — View Citation

Gola M, Magnuski M, Szumska I, Wróbel A. EEG beta band activity is related to attention and attentional deficits in the visual performance of elderly subjects. Int J Psychophysiol. 2013 Sep;89(3):334-41. doi: 10.1016/j.ijpsycho.2013.05.007. Epub 2013 May 18. — View Citation

Hirsch L, Jette N, Frolkis A, Steeves T, Pringsheim T. The Incidence of Parkinson's Disease: A Systematic Review and Meta-Analysis. Neuroepidemiology. 2016;46(4):292-300. doi: 10.1159/000445751. Epub 2016 Apr 23. Review. — View Citation

Lenka A, Jhunjhunwala KR, Saini J, Pal PK. Structural and functional neuroimaging in patients with Parkinson's disease and visual hallucinations: A critical review. Parkinsonism Relat Disord. 2015 Jul;21(7):683-91. doi: 10.1016/j.parkreldis.2015.04.005. Epub 2015 Apr 17. Review. — View Citation

Magosso E, De Crescenzio F, Ricci G, Piastra S, Ursino M. EEG Alpha Power Is Modulated by Attentional Changes during Cognitive Tasks and Virtual Reality Immersion. Comput Intell Neurosci. 2019 Jun 25;2019:7051079. doi: 10.1155/2019/7051079. eCollection 2019. — View Citation

Navaratnam P, Arcona S, Friedman HS, Leoni M, Shaik S, Sasane R. Natural history and patterns of treatment change in Parkinson's disease: A retrospective chart review. Clin Park Relat Disord. 2021 Dec 8;6:100125. doi: 10.1016/j.prdoa.2021.100125. eCollection 2022. — View Citation

Sveinbjornsdottir S. The clinical symptoms of Parkinson's disease. J Neurochem. 2016 Oct;139 Suppl 1:318-324. doi: 10.1111/jnc.13691. Epub 2016 Jul 11. Review. — View Citation

Taylor AE, Saint-Cyr JA, Lang AE. Frontal lobe dysfunction in Parkinson's disease. The cortical focus of neostriatal outflow. Brain. 1986 Oct;109 ( Pt 5):845-83. — View Citation

Tran TN, Ha UNL, Nguyen TM, Nguyen TD, Vo KNC, Dang TH, Trinh PMP, Truong D. The effect of Non-Motor symptoms on Health-Related quality of life in patients with young onset Parkinson's Disease: A single center Vietnamese Cross-Sectional study. Clin Park Relat Disord. 2021 Nov 24;5:100118. doi: 10.1016/j.prdoa.2021.100118. eCollection 2021. — View Citation

Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1. Review. — View Citation

Weintraub D, Claassen DO. Impulse Control and Related Disorders in Parkinson's Disease. Int Rev Neurobiol. 2017;133:679-717. doi: 10.1016/bs.irn.2017.04.006. Epub 2017 Jun 1. Review. — View Citation

Wen D, Lan X, Zhou Y, Li G, Hsu SH, Jung TP. The Study of Evaluation and Rehabilitation of Patients With Different Cognitive Impairment Phases Based on Virtual Reality and EEG. Front Aging Neurosci. 2018 Apr 3;10:88. doi: 10.3389/fnagi.2018.00088. eCollection 2018. — View Citation

Zietsch BP, Hansen JL, Hansell NK, Geffen GM, Martin NG, Wright MJ. Common and specific genetic influences on EEG power bands delta, theta, alpha, and beta. Biol Psychol. 2007 May;75(2):154-64. Epub 2007 Jan 25. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power spectral density in the frequency of motor imagery from primary motor cortex	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
Primary	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).	2 weeks