Mild Cognitive ImpairmentRVEC-DCLNCT06977815
Non-randomized Clinical Trial on Cognitive Stimulation With Virtual Reality in Patients With Mild Cognitive Impairment
A study testing VR-Enhanced Cognitive Rehabilitation and Standard Cognitive Rehabilitation in people with Mild Cognitive Impairment and Cognitive Dysfunction, run by Badalona Serveis Assistencials at 1 site in Spain.
Trial summary
The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Dysfunction, Aging
- What is being tested?
- VR-Enhanced Cognitive Rehabilitation and Standard Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 4 Oct 2024to 22 May 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥60 years, classified as having mild cognitive impairment or early cognitive impairment, with MMSE >20, regularly attending cognitive stimulation sessions at the CSSC day hospital and able to provide informed consent or consent through a legal representative.
Who cannot join
- Severe or unstable illness interfering with participation, severe psychiatric symptoms that could be exacerbated by VR, severe visual or hearing impairment preventing participation, high sensitivity to motion sickness, epilepsy, or inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.
Read the detailed description
This clinical trial evaluates a cognitive rehabilitation program enhanced with virtual reality (VR) for older adults with mild cognitive impairment (MCI). The study investigates whether adding immersive VR exercises to a conventional program improves cognitive performance compared to standard cognitive rehabilitation alone.
All participants take part in a structured, computer-based cognitive training program delivered over 12 weeks. Sessions occur twice per week, with participants completing at least 20 and up to 22 sessions depending on clinic scheduling. The intervention group receives an additional 15-20 minutes of immersive VR content at the end of each session. VR exercises target attention, memory, and executive functioning, aiming to increase engagement and therapeutic value.
This trial complements a previously registered pilot study (ClinicalTrials.gov Identifier: NCT06155721) and builds on its published results.
Cognitive performance will be assessed using standardized neuropsychological tests including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Digit Span, Trail Making Test (TMT), and Symbol Digit Modalities Test (SDMT). Functional capacity will be evaluated using the Lawton-Brody scale. Usability and satisfaction with the VR system will be measured in the intervention group using the System Usability Scale (SUS) and a custom satisfaction questionnaire.
The study was implemented pragmatically within routine clinical care. Allocation followed the pre-existing attendance schedule of the psychogeriatric day hospital. For logistical and ethical reasons related to service implementation, one comparator group was later offered the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. Analyses will distinguish unique participants from rehabilitation episodes to account for this sequential access.
The study has been approved by the Germans Trias i Pujol University Hospital Research Ethics Committee (PI-24-210) and complies with the Declaration of Helsinki and the European General Data Protection Regulation (GDPR).
- Conditions
- Mild Cognitive Impairment, Cognitive Dysfunction, Aging
- Being tested
- VR-Enhanced Cognitive Rehabilitation, Standard Cognitive Rehabilitation
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Older Adults, VR-Enhanced Therapy, Neurocognitive Disorders, Cognitive Stimulation, Gerontology
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Enhanced Cognitive RehabilitationBehavioural
Also called Virtual Reality Cognitive Support
A program consisting of 45-minute computer-based cognitive rehabilitation exercises, enhanced with 15-20 minutes of immersive virtual reality (VR) content per session. The VR component targets memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks.
Standard Cognitive RehabilitationBehavioural
Also called Computer-Based Cognitive Training
A program consisting of 45-minute computer-based cognitive rehabilitation exercises targeting memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks. No VR content is included.
| Study group | Role | What they receive |
|---|---|---|
| VR-Enhanced Cognitive Rehabilitation | Experimental | Participants receive a computer-based cognitive rehabilitation program supplemented with immersive virtual reality exercises. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. Receives: Behavioral: VR-Enhanced Cognitive Rehabilitation |
| Standard Cognitive Rehabilitation | Active comparator | Participants receive a standard computer-based cognitive rehabilitation program. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. Receives: Behavioral: Standard Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
MoCA is a 30-point screening tool for global cognitive function, assessing memory, attention, language, visuospatial skills, and executive function.
Score Range: 0 to 30 points
- Higher scores means better global cognition function
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
MMSE is a 30-point questionnaire evaluating orientation, attention, recall, language, and visual construction Score Range: 0 to 30 points. Higher scores means better global cognition function
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Short-Term Memory as Measured by the Digit Span Test (Forward Span)
Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points Higher scores reflect better performance.
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Working Memory as Measured by the Digit Span Test (Backward Span)
Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
TMT-A measures visual attention and processing speed. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes.
Lower times (faster completion) indicate better visuospatial attention.
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
TMT-B assesses alternating attention and executive control. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes.
Lower times (faster completion) indicate better alternating attention.
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
SDMT: Symbol Digit Modalities Test. The Symbol Digit Modalities Test (SDMT) measures processing speed, attention, and visual-motor coordination. During the test, participants are required to match abstract symbols with corresponding numbers using a key. The total raw score is calculated as the number of correct symbol-digit pairs completed within a 90-second interval. There is no fixed maximum score, as it varies based on individual performance.
Higher scores indicate better processing speed and cognitive performance.
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale
The Lawton-Brody Instrumental Activities of Daily Living Scale evaluates functional independence in activities such as telephone use, shopping, cooking, and managing finances. Scores range from 0 to 8, with higher scores indicating greater independence. Each task is scored as independent (1) or dependent (0).
Measured: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Secondary outcomes (4)
Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache).
Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.
Measured: Post-intervention (Week 12, within 1 week after last session)
Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale
Participants rate the comfort and tolerability of the Meta Quest 2 or 3 headset after the final session. The scale includes 8 items addressing physical discomfort (e.g., weight, visual strain, dizziness, fatigue, and headache).
Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate greater headset tolerability and comfort.
Measured: Post-intervention (Week 12, within 1 week after last session)
Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
An adapted SUS completed by professionals delivering the intervention. The 8 items assess perceived usability, integration into clinical workflow, and ease of use for patients.
Score Range: 0 to 100 Interpretation: Higher scores indicate better usability.
Measured: Post-intervention (Week 12, within 1 week after last session)
Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire
Professionals rate their perception of how comfortable and manageable the VR headset is for patients. The 3 items assess concerns such as weight, usability of controls, and prolonged wear tolerance.
Score Range: 0 to 100 (converted from Likert responses) Interpretation: Higher scores indicate better perceived comfort and usability for patients.
Measured: Post-intervention (Week 12, within 1 week after last session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start4 Oct 2024
- Primary completion29 Apr 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated according to pre-existing attendance groups in the psychogeriatric day hospital. One group received standard cognitive rehabilitation supplemented with virtual reality (VR), while the comparator group received standard cognitive rehabilitation alone. For pragmatic service-implementation reasons, one comparator group was subsequently offered access to the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. This sequential access was based on clinical logistics and did not involve randomization or allocation concealment.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badalona Serveis Assistencials
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ferrer Costa, Badalona Serveis Assistencials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977815
- Sponsor's protocol ID
- PI-24-210
- Acronym
- RVEC-DCL
- Status last verified
- Jul 2026
- First submitted
- 1 May 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferrer Costa J, Ciudad MJ, Gonzalez Abad M, Rodriguez Garcia JL. Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment. J Med Ext Real. 2025 Mar 21;2(1):30-42. doi: 10.1089/jmedxr.2024.0051. eCollection 2025.
PubMed 42558145
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo Clínico No Aleatorizado Sobre la Estimulación Cognitiva Con Realidad Virtual en Pacientes Con Deterioro Cognitivo Leve
- ClinicalTrials.gov ID
- NCT06977815
- Acronym / sponsor ID
- RVEC-DCL / PI-24-210
- Conditions
- Mild Cognitive Impairment, Cognitive Dysfunction, Aging
- Keywords
- Virtual Reality, Cognitive Rehabilitation, Older Adults, VR-Enhanced Therapy, Neurocognitive Disorders, Cognitive Stimulation, Gerontology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Badalona Serveis AssistencialsUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if adding virtual reality (VR) to a cognitive training program helps improve cognitive performance in older adults with mild cognitive impairment (MCI). In this study, all participants will take part in a 12-week computer-based cognitive rehabilitation program. One group will also use immersive VR for 15-20 minutes at the end of each session. Participants will attend 2 sessions per week, completing at least 20 sessions and up to 22, depending on the clinic's schedule. Researchers will measure changes in attention, memory, and thinking skills using standard cognitive tests. They will also collect feedback on how participants experience the VR exercises.
Detailed description
This clinical trial evaluates a cognitive rehabilitation program enhanced with virtual reality (VR) for older adults with mild cognitive impairment (MCI). The study investigates whether adding immersive VR exercises to a conventional program improves cognitive performance compared to standard cognitive rehabilitation alone.
All participants take part in a structured, computer-based cognitive training program delivered over 12 weeks. Sessions occur twice per week, with participants completing at least 20 and up to 22 sessions depending on clinic scheduling. The intervention group receives an additional 15-20 minutes of immersive VR content at the end of each session. VR exercises target attention, memory, and executive functioning, aiming to increase engagement and therapeutic value.
This trial complements a previously registered pilot study (ClinicalTrials.gov Identifier: NCT06155721) and builds on its published results.
Cognitive performance will be assessed using standardized neuropsychological tests including the Montreal Cognitive Assessment (MoCA), Mini-Mental State Examination (MMSE), Digit Span, Trail Making Test (TMT), and Symbol Digit Modalities Test (SDMT). Functional capacity will be evaluated using the Lawton-Brody scale. Usability and satisfaction with the VR system will be measured in the intervention group using the System Usability Scale (SUS) and a custom satisfaction questionnaire.
The study was implemented pragmatically within routine clinical care. Allocation followed the pre-existing attendance schedule of the psychogeriatric day hospital. For logistical and ethical reasons related to service implementation, one comparator group was later offered the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. Analyses will distinguish unique participants from rehabilitation episodes to account for this sequential access.
The study has been approved by the Germans Trias i Pujol University Hospital Research Ethics Committee (PI-24-210) and complies with the Declaration of Helsinki and the European General Data Protection Regulation (GDPR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated according to pre-existing attendance groups in the psychogeriatric day hospital. One group received standard cognitive rehabilitation supplemented with virtual reality (VR), while the comparator group received standard cognitive rehabilitation alone. For pragmatic service-implementation reasons, one comparator group was subsequently offered access to the VR-supported intervention after completing its standard rehabilitation phase and post-intervention assessment. This sequential access was based on clinical logistics and did not involve randomization or allocation concealment.
| Arm | Type | Receives |
|---|---|---|
| VR-Enhanced Cognitive Rehabilitation | Experimental | Behavioral: VR-Enhanced Cognitive RehabilitationParticipants receive a computer-based cognitive rehabilitation program supplemented with immersive virtual reality exercises. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. |
| Standard Cognitive Rehabilitation | Active comparator | Behavioral: Standard Cognitive RehabilitationParticipants receive a standard computer-based cognitive rehabilitation program. The program is delivered in two sessions per week over 12 weeks, for a total of approximately 20 to 22 sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥60 years, classified as having mild cognitive impairment or early cognitive impairment, with MMSE >20, regularly attending cognitive stimulation sessions at the CSSC day hospital and able to provide informed consent or consent through a legal representative.
Key exclusion criteria (1 listed)
- Severe or unstable illness interfering with participation, severe psychiatric symptoms that could be exacerbated by VR, severe visual or hearing impairment preventing participation, high sensitivity to motion sickness, epilepsy, or inability or unwillingness to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Enhanced Cognitive RehabilitationAlso: Virtual Reality Cognitive SupportA program consisting of 45-minute computer-based cognitive rehabilitation exercises, enhanced with 15-20 minutes of immersive virtual reality (VR) content per session. The VR component targets memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks. | Behavioural | VR-Enhanced Cognitive Rehabilitation |
| Standard Cognitive RehabilitationAlso: Computer-Based Cognitive TrainingA program consisting of 45-minute computer-based cognitive rehabilitation exercises targeting memory, attention, and executive function. Sessions are delivered twice per week over 12 weeks. No VR content is included. | Behavioural | Standard Cognitive Rehabilitation |
Primary outcome
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
MoCA is a 30-point screening tool for global cognitive function, assessing memory, attention, language, visuospatial skills, and executive function. Score Range: 0 to 30 points - Higher scores means better global cognition function
Global Cognition as Measured by the Mini-Mental State Examination (MMSE)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
MMSE is a 30-point questionnaire evaluating orientation, attention, recall, language, and visual construction Score Range: 0 to 30 points. Higher scores means better global cognition function
Short-Term Memory as Measured by the Digit Span Test (Forward Span)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Forward Digit Span measures verbal short-term memory. Score Range: 0 to 9 points Higher scores reflect better performance.
Working Memory as Measured by the Digit Span Test (Backward Span)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
Backward Digit Span assesses working memory and mental manipulation. Score Range: 0 to 9 points. Higher scores indicate better working memory.
Visuospatial Attention as Measured by the Trail Making Test Part A (TMT-A)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
TMT-A measures visual attention and processing speed. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better visuospatial attention.
Executive Function as Measured by the Trail Making Test Part B (TMT-B)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
TMT-B assesses alternating attention and executive control. The outcome is time to completion measured in seconds, typically ranging from several seconds to several minutes. Lower times (faster completion) indicate better alternating attention.
Processing Speed as Measured by the Symbol Digit Modalities Test (SDMT)
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
SDMT: Symbol Digit Modalities Test. The Symbol Digit Modalities Test (SDMT) measures processing speed, attention, and visual-motor coordination. During the test, participants are required to match abstract symbols with corresponding numbers using a key. The total raw score is calculated as the number of correct symbol-digit pairs completed within a 90-second interval. There is no fixed maximum score, as it varies based on individual performance. Higher scores indicate better processing speed and cognitive performance.
Functional Capacity as Measured by the Lawton-Brody Instrumental Activities of Daily Living Scale
Time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)
The Lawton-Brody Instrumental Activities of Daily Living Scale evaluates functional independence in activities such as telephone use, shopping, cooking, and managing finances. Scores range from 0 to 8, with higher scores indicating greater independence. Each task is scored as independent (1) or dependent (0).
4 secondary outcomes
Patient Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
Time frame: Post-intervention (Week 12, within 1 week after last session)
Patient Comfort and Tolerability of the VR Headset as Measured by an 8-Item Adapted Scale
Time frame: Post-intervention (Week 12, within 1 week after last session)
Clinician Usability of the VR System as Measured by the Adapted 8-Item System Usability Scale (SUS)
Time frame: Post-intervention (Week 12, within 1 week after last session)
Clinician Perception of VR Headset Comfort for Patients as Measured by a 3-Item Questionnaire
Time frame: Post-intervention (Week 12, within 1 week after last session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 42558145Ferrer Costa J, Ciudad MJ, Gonzalez Abad M, Rodriguez Garcia JL. Virtual Reality in Cognitive Rehabilitation: A Pilot Study on Usability and Preliminary Clinical Outcomes in Seniors with Mild Cognitive Impairment. J Med Ext Real. 2025 Mar 21;2(1):30-42. doi: 10.1089/jmedxr.2024.0051. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Enhanced Cognitive Rehabilitation and Standard Cognitive Rehabilitation in people with Mild Cognitive Impairment and Cognitive Dysfunction, run by Badalona Serveis Assistencials at 1 site in Spain.
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 1 inclusion and 1 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 8 Jul 2026. 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 Spain. 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?
Global Cognition as Measured by the Montreal Cognitive Assessment (MoCA) (time frame: Baseline and immediately post-intervention (Week 12, within 1 week after last session)). The study lists 8 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 NCT06977815, which also lists 1 linked publication.
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 8 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.