Efficacy of Cognitive Rehabilitation Using Virtual Reality and Computer-based Cognitive Stimulation on Cognitive Impairment Associated to Movement Disorders

NCT05769972 | Completed DMC

• 1 other identifier: IIBSP-MOV-2021-28
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Mild cognitive impairment associated with movement disorders occurs in up to one third of patients in early stages of the disease, and confers an increased risk of developing dementia. Non-pharmacological interventions to improve cognition have so far been based on computer-based cognitive stimulation and rehabilitation programs. These interventions base their mechanism of action on neuroplasticity and how improvements in cognitive function will generalize to functional improvement. Despite having shown certain indicators of efficacy in previous exploratory studies and clinical trials, cognitive rehabilitation continues to show insufficient evidence and requires further study. To date, there are no previous studies using immersive virtual reality (IVR) to improve cognition. Both IVR and cognitive stimulation are based on the premise that they allow the simulation of ecological environments for rehabilitation than conventional rehabilitation, as well as being more efficient by allowing control of extraneous variables and providing safe spaces for patients. The only PD rehabilitation studies that have been conducted using IVR aimed to improve gait and balance disturbances compared to conventional physiotherapy treatment or non-immersive virtual reality (NIVR). We hypothesize that a cognitive rehabilitation program using IVR or computer-mediated cognitive stimulation could have a greater beneficial effect on the cognitive status of patients with cognitive impairment associated with movement disorders compared to other modalities such as music therapy, delaying the worsening of cognitive functions.

Conditions

Parkinson Disease; Huntington Disease

Keywords

Cognitive impairment; Cognitive rehabilitation; Virtual reality; Music therapy; Computer-based cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• Parkinson's Disease - Cognitive Rating Scale (PD-CRS)

  24 weeks

Study Arms (4)

Immersive Virtual Reality (Parkinson's disease)

EXPERIMENTAL

Device: Immersive Virtual Reality (Parkinson's disease)

Computer-based cognitive rehabilitation (Parkinson's disease)

ACTIVE COMPARATOR

Device: Computer-based cognitive rehabilitation (Parkinson's disease)

Computer-based cognitive rehabilitation (Huntington's disease)

EXPERIMENTAL

Device: Computer-based cognitive rehabilitation (Huntington's disease)

Music-therapy (Huntington's disease)

ACTIVE COMPARATOR

Behavioral: Music-therapy (Huntington's disease)

Interventions

Immersive Virtual Reality (Parkinson's disease) DEVICE

This tool involves placing sensors in the space where it will be used, wearing virtual reality glasses, and using controllers to create realistic fictional spaces and interact with them. The program used for the study consists of an interface and a set of tasks designed specifically for the type of cognitive process deficits related to frontal function (executive functions) that are predominantly presented by patients with cognitive impairment associated with Parkinson's disease. This is due to the effect of the disease's pathophysiology on a series of brain circuits and structures that range from the basal ganglia to the frontal lobe. The affected functions correspond to the individual's ability to plan, sequence, organize, make decisions, be flexible, abstract, conceptualize, inhibit, among others.

Immersive Virtual Reality (Parkinson's disease)

Computer-based cognitive rehabilitation (Parkinson's disease) DEVICE

This consists of a 24-week computerized cognitive stimulation program using the NeuronUp software. The intervention includes a limited number of tasks developed ad hoc by NeuronUp and the researchers specifically aimed at stimulating the cognitive domains typically affected in movement disorders. These are cognitive processes mostly ascribed to frontal function, as well as other less prevalent but equally disabling processes mainly associated with basal ganglia and fronto-striatal circuitry, such as executive functions, attention and working memory, language, processing speed, and social cognition. Thus, the programs are the same for PD and HD, although the parameters of the number of errors, level of difficulty, and number of correct answers required to advance to the next level have been adjusted to be more demanding in PD and less in HD, with the aim of customizing this type of intervention to the clinical characteristics of each disease.

Computer-based cognitive rehabilitation (Parkinson's disease)

Computer-based cognitive rehabilitation (Huntington's disease) DEVICE

This consists of a 24-week computerized cognitive stimulation program using the NeuronUp software. The intervention includes a limited number of tasks developed ad hoc by NeuronUp and the researchers specifically aimed at stimulating the cognitive domains typically affected in movement disorders. These are cognitive processes mostly ascribed to frontal function, as well as other less prevalent but equally disabling processes mainly associated with basal ganglia and fronto-striatal circuitry, such as executive functions, attention and working memory, language, processing speed, and social cognition. Thus, the programs are the same for PD and HD, although the parameters of the number of errors, level of difficulty, and number of correct answers required to advance to the next level have been adjusted to be more demanding in PD and less in HD, with the aim of customizing this type of intervention to the clinical characteristics of each disease.

Computer-based cognitive rehabilitation (Huntington's disease)

Music-therapy (Huntington's disease) BEHAVIORAL

The process used in each session will be standardized, while the content will be flexible, administering the guidelines according to the mood of the patients and their needs at that time. The therapist's clinical experience will guide them, providing sufficient space for flexible adaptation within the treatment guideline. While the sessions will be standardized, without limiting the music therapist in their interactions, the intervention itself will be applied during the experimental period, using all of the cognitive music therapy exercises detailed below in all groups: auditive perception training, musical sensorial orientation, control of musical attention, training of musical executive function, training in musical mnemotecnia and associative training of mood and musical memory

Music-therapy (Huntington's disease)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient capable of understanding, signing and dating the written informed consent at baseline visit prior to randomization.
• Patient diagnosed with Parkinson's disease (Movement Disorder Society PD Criteria) or Huntington's disease.
• Patient with Hoehn and Yahr stage I-III for PD, and Shoulson and Fahn stage I-II for HD.
• Patient with a score on the Parkinson's Disease Cognitive Rating Scale (PD-CRS) \>83, who present subjective memory complaints will be included in "group I: subjective memory complaints".
• Patient with a score on the Parkinson's Disease Cognitive Rating Scale (PD-CRS) between 64 and 83, both inclusive, will be included in "group II: mild cognitive impairment".
• Patient diagnosed with Parkinson's disease with stable dopaminergic treatment in the last 4 weeks.
• Patient capable and willing to comply with study visits as detailed in the protocol.

You may not qualify if:

• Illiterate patients.
• Patients with severe vision or hearing impairment.
• History of deep brain stimulation surgery.
• Patients diagnosed with severe dementia (possible or probable) associated with Parkinson's disease, according to the Clinical Diagnostic Criteria for Dementia Associated with PD with a score of \>2 on the CRD or with Huntington's disease.
• Patients with active psychosis in the form of incapacitating delusional ideation.
• Patients who were under experimental treatment in the 2 months prior to the selection period.
• Patients with any of the following conditions:
• Life expectancy of less than 6 months.
• Any severe or uncontrolled medical condition.
• Patients with a history of poor treatment compliance or drug/alcohol abuse that may interfere with the patient's ability to comply with the study protocol or give informed consent.
• Pregnancy or breastfeeding.
• Contraindications for MRI\*.
• Except for patients with Parkinson's disease (PD), since MRI is optional for these patients. Therefore, if there are contraindications for MRI, they can still participate without undergoing MRI.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

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MeSH Terms

Conditions

Parkinson Disease; Huntington Disease; Cognitive Dysfunction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind: outcomes assessor do not know where the participants are allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventions or each disease: Parkinson's disease:

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: October 13, 2021
• Primary Completion: September 21, 2022
• Study Completion: December 1, 2023
• Last Updated: November 18, 2025

Record last verified: 2023-03

Locations

ES (1)