NCT06313931

Brief Summary

This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 1, 2024

Last Update Submit

March 8, 2024

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive ImpairmentImmersive Virtual RealityInstrumental Activities of Daily LivingMotor-cognitive TrainingGeriatric Depression

Outcome Measures

Primary Outcomes (3)

  • Spanish version of the Montreal Cognitive Assessment (MoCA-S)

    Scores in the MoCA-S scale. Higher scores mean a better outcome.

    6 weeks

  • Short Geriatric Depression Scale (SGDS-S)

    Scores in the SGDS scale. Higher scores mean a worse outcome.

    6 weeks

  • Instrumental Activities of Daily Living Scale (IADL-S)

    Scores in the IADL scale. Higher scores mean a better outcome.

    6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group

Device: cognitive training via immersive virtual realityOther: motor stimulation

Control group

ACTIVE COMPARATOR

Control group

Other: cognitive training via paper and pencilOther: motor stimulation

Interventions

cognitive training via immersive virtual realityDEVICE

20 minutes per session, twice a week for six weeks (totaling 12 sessions), using the cupboard task application.

Experimental group
cognitive training via paper and pencilOTHER

20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards.

Control group
motor stimulationOTHER

motor stimulation for 12 sessions (20 minutes per session)

Control groupExperimental group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 or older
  • Community-dwelling, not in nursing homes
  • Physically functional
  • Understanding and voluntary consent
  • Mild Cognitive Impairment (MCI)
  • MoCA score of 19-25

You may not qualify if:

  • Clinical dementia diagnosis
  • MoCA ≤ 18 indicating probable dementia
  • Neurological disorders including stroke or TBI in the last year
  • History of mental/psychiatric disorders
  • Substance abuse
  • Difficulty using VR headset and controllers
  • Medical conditions affecting trial participation
  • Visual/hearing impairments
  • Communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zaragoza

Teruel, 44003, Spain

Location

Related Publications (1)

  • Buele J, Aviles-Castillo F, Del-Valle-Soto C, Varela-Aldas J, Palacios-Navarro G. Effects of a dual intervention (motor and virtual reality-based cognitive) on cognition in patients with mild cognitive impairment: a single-blind, randomized controlled trial. J Neuroeng Rehabil. 2024 Aug 1;21(1):130. doi: 10.1186/s12984-024-01422-w.

    PMID: 39090664DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Guillermo Palacios, PhD

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 15, 2024

Study Start

July 3, 2023

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)