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Parkinson DiseaseNCT05403788

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

A study testing Intervention with virtual reality in people with Parkinson Disease, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Parkinson Disease
What is being tested?
Intervention with virtual reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChile
Study dates
1 Mar 2021to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Mental diseases
  • Migraines
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Corporación de Rehabilitación Club de Leones Cruz del Sur

    Punta Arenas, Region of Magallanes, 6211525

Other trials in Chile

About this study

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.

Read the detailed 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.

Being tested
Intervention with virtual reality
Keywords
Parkinson's disease, virtual reality, cognitive functions, alpha band, beta band, cerebral lobes, electroencephalography
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention with virtual realityDevice

    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.

Study groups in NCT05403788
Study groupRoleWhat they receive
Intervention with virtual realityExperimentalEach subject will receive a single session of exercises with the OCULUS QUEST2 (OCULUS VR, USA) and a hand tracking software (Hand Physics Lab, Holonautic, Switzerland). Brain function monitoring will be made by an EEG system ENOBIO 20 (Neuro-electrics, Spain) positioned over subject head. Intervention consisted of exercises with upper limbs and visual feedback. These activities were projected stereoscopically on VR googles.
Receives: Device: Intervention with virtual reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  2. 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).

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2022
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403788
Sponsor's protocol ID
CorporacionRCLCS0007
Status last verified
May 2022
First submitted
27 May 2022
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28150045

  • 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.

    PubMed 27401947

  • 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.

    PubMed 27105081

  • 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.

    PubMed 34950865

  • 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.

    PubMed 34927047

  • 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.

    PubMed 28802938

  • Duchesne C, Lungu O, Nadeau A, Robillard ME, Bore 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.

    PubMed 26263381

  • 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. No abstract available.

    PubMed 29666577

  • 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.

    PubMed 31623622

  • 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. doi: 10.1016/s0165-0270(00)00324-1.

    PubMed 11163409

  • 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. doi: 10.1016/j.biopsycho.2007.01.004. Epub 2007 Jan 25.

    PubMed 17316957

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

    PubMed 21687773

  • 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.

    PubMed 18929561

  • 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.

    PubMed 22503538

  • 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.

    PubMed 31341468

Questions about this trial

What is this clinical trial studying?

A study testing Intervention with virtual reality in people with Parkinson Disease, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Power spectral density in the frequency of motor imagery from primary motor cortex (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403788, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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