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Completed

NCT Number: NCT05403788

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention with virtual reality

Device

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.

Primary outcomes

  1. Power spectral density in the frequency of motor imagery from primary motor cortex

    Time frame: 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).

  2. Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention

    Time frame: 2 weeks

    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).

Sponsors and collaborators

Lead sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Other

Collaborators

  • Colombian School of Engineering Julio Garavito
  • Universidad del Rosario

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2022
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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