Mild Cognitive ImpairmentrTMS+iVCTNCT06024473
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
A study testing rTMS and rTMS+iVCT in people with Mild Cognitive Impairment and Caregiver Burden, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
Trial summary
This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Caregiver Burden, Mental Health Issue
- What is being tested?
- rTMS and rTMS+iVCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 55 and over
- previous diagnosis of Mild Cognitive Impairment
- Score of 18 or over on the MoCA during pre-screening procedures.
Who cannot join
- below 55 years old
- Do not pass the TMS Adult Safety Screening
- Taking medications known to increase risk of seizure
- Taking ototoxic medications
- Those with implanted device
- History of bipolar disorder
Show all 14Show fewer
- History of Tourette's syndrome or presence of motor tics
- History of seizures/ seizures in first degree relatives
- History of stroke, aneurysm, or cranial neurosurgery
- Current alcohol related disorder needing medical treatment
- History of abnormal electroencephalogram (EEG)
- History of motion sickness, nausea, vomiting, seizures, or migraine
- Significant balance/gait impairments/history of falls
- History of hyperacusis or photophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Central Arkansas VA Healthcare system
Little Rock, Arkansas, 72114
Ian Moore, PhD, 501-257-2152, ian.moore@va.gov
lasi.mcghee@va.gov
About this study
This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality cognitive training (iVCT) program. The goals of this clinical trail are as follows:
- Examine if rTMS+iVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups
- Examine if rTMS+iVCT intervention improves participants mental health symptoms, functional abilities, and quality of life more than control or rTMS only groups
- Examine the impact of rTMS+iVCT intervention on caregiver burden.
Eligible participants will be assigned to a standard treatment (no intervention control) group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only group will receive rTMS treatments for five days per week for two weeks (total of ten sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training for five days a week for two weeks (total of ten sessions). All participants will then repeat testing 2 weeks and three months after baseline testing to assess for possible treatment related changes and lasting effects.
Read the detailed description
The primary objective of this pilot study is to assess if combined treatment with repetitive transcranial magnetic stimulation (rTMS) and immersive virtual reality mediated cognitive training program (iVCT) improves cognitive, emotional, and functional abilities in participants with mild cognitive impairment (MCI) compared to usual care. Secondary objective of the study is assess if rTMS+iVCT treatment improves caregiver burden.
Older Veterans (N=50) age ≥ 55 years with mild cognitive impairment will be recruited. All participants will be screened for suitability for the rTMS and iVCT treatments. Those eligible (N=30) will complete a baseline assessment of their cognitive, emotional, and functional abilities and caregiver burden (Visit 1). Participants (N=30) will be randomly assigned to a rTMS group, rTMS+iVCT group, and control group.. Participants in the rTMS group will receive rTMS treatment daily for 5 days of the week for 2 weeks. Participants in the rTMS+iVCT group will receive rTMS treatment followed by 30-60 minutes of iVCT intervention daily for 5 days of the week for 2 weeks. Participants in the control group will receive usual care. All testing will be repeated posttreatment at 2 weeks (Visit 2) and at 3 months(Visit 3) .
Innovations include combination of two non-pharmacological interventions and the inclusion of 3-month post-treatment testing to assess the durability of changes. Feedback will be gathered to improve the treatment program. Assuming positive findings, this research will help establish a new treatment modality for improving the cognitive, emotional, and functional abilities in MCI.
- Being tested
- rTMS, rTMS+iVCT
- Keywords
- repetitive Transcranial Magnetic Stimulation, immersive virtual reality, Neuropsychiatric Symptoms, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Transcranial Magnetic Stimulation
rTMS+iVCTDevice
Transcranial Magnetic Stimulation and immersive virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | This arm will be followed without intervention |
| rTMS | Active comparator | This group will be randomized to receive rTMS treatment Receives: Device: rTMS |
| rTMS+iVCT | Experimental | This group will be randomized to receive rTMS and iVCT treatment Receives: Device: rTMS+iVCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hopkins Verbal Leaning Test Standard Score
range: <55 to >130 - higher score is improvement
Measured: baseline, 2 weeks, 3 months
Secondary outcomes (2)
Change in NPI
Range: 0-33 Lower score is improvement
Measured: baseline, 2 weeks, 3 months
Change in Functional Activities Questionnaire score
Range: 0-30 Lower score is improvement
Measured: baseline, 2 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start31 Mar 2024
- Primary completion31 Mar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Arkansas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024473
- Sponsor's protocol ID
- 1762307
- Acronym
- rTMS+iVCT
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To ensure participant confidentiality, the database will not be made available for public access. One year post completion of the funded study or upon acceptance of the data for publication, deidentified data will be made available to interested parties. Raw data from neuropsychological testing will only be provided to qualified researchers (e.g. neuropsychologists) to prevent misrepresentation. All other data gathered related to clinical, medical, mental health, and psychosocial histories (sans confidential identifiers) will be made available by the PI or research mentor for future research. The PI and research mentor will assume responsibility for ensuring that participant confidentiality is maintained. Prior to release of data, investigators will need to consent to a VA supported data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
- ClinicalTrials.gov ID
- NCT06024473
- Acronym / sponsor ID
- rTMS+iVCT / 1762307
- Keywords
- repetitive Transcranial Magnetic Stimulation, immersive virtual reality, Neuropsychiatric Symptoms, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Arkansas Veterans Healthcare SystemUS federal agency
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Sep 2023 (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.
This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality cognitive training (iVCT) program. The goals of this clinical trail are as follows:
- Examine if rTMS+iVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups
- Examine if rTMS+iVCT intervention improves participants mental health symptoms, functional abilities, and quality of life more than control or rTMS only groups
- Examine the impact of rTMS+iVCT intervention on caregiver burden.
Eligible participants will be assigned to a standard treatment (no intervention control) group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only group will receive rTMS treatments for five days per week for two weeks (total of ten sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training for five days a week for two weeks (total of ten sessions). All participants will then repeat testing 2 weeks and three months after baseline testing to assess for possible treatment related changes and lasting effects.
Detailed description
The primary objective of this pilot study is to assess if combined treatment with repetitive transcranial magnetic stimulation (rTMS) and immersive virtual reality mediated cognitive training program (iVCT) improves cognitive, emotional, and functional abilities in participants with mild cognitive impairment (MCI) compared to usual care. Secondary objective of the study is assess if rTMS+iVCT treatment improves caregiver burden.
Older Veterans (N=50) age ≥ 55 years with mild cognitive impairment will be recruited. All participants will be screened for suitability for the rTMS and iVCT treatments. Those eligible (N=30) will complete a baseline assessment of their cognitive, emotional, and functional abilities and caregiver burden (Visit 1). Participants (N=30) will be randomly assigned to a rTMS group, rTMS+iVCT group, and control group.. Participants in the rTMS group will receive rTMS treatment daily for 5 days of the week for 2 weeks. Participants in the rTMS+iVCT group will receive rTMS treatment followed by 30-60 minutes of iVCT intervention daily for 5 days of the week for 2 weeks. Participants in the control group will receive usual care. All testing will be repeated posttreatment at 2 weeks (Visit 2) and at 3 months(Visit 3) .
Innovations include combination of two non-pharmacological interventions and the inclusion of 3-month post-treatment testing to assess the durability of changes. Feedback will be gathered to improve the treatment program. Assuming positive findings, this research will help establish a new treatment modality for improving the cognitive, emotional, and functional abilities in MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –This arm will be followed without intervention |
| rTMS | Active comparator | Device: rTMSThis group will be randomized to receive rTMS treatment |
| rTMS+iVCT | Experimental | Device: rTMS+iVCTThis group will be randomized to receive rTMS and iVCT treatment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 55 and over
- previous diagnosis of Mild Cognitive Impairment
- Score of 18 or over on the MoCA during pre-screening procedures.
Key exclusion criteria (14 listed)
- below 55 years old
- Do not pass the TMS Adult Safety Screening
- Taking medications known to increase risk of seizure
- Taking ototoxic medications
- Those with implanted device
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 |
|---|---|---|
| rTMSTranscranial Magnetic Stimulation | Device | rTMS |
| rTMS+iVCTTranscranial Magnetic Stimulation and immersive virtual reality | Device | rTMS+iVCT |
Primary outcome
Change in Hopkins Verbal Leaning Test Standard Score
Time frame: baseline, 2 weeks, 3 months
range: <55 to >130 - higher score is improvement
2 secondary outcomes
Change in NPI
Time frame: baseline, 2 weeks, 3 months
Change in Functional Activities Questionnaire score
Time frame: baseline, 2 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. To ensure participant confidentiality, the database will not be made available for public access. One year post completion of the funded study or upon acceptance of the data for publication, deidentified data will be made available to interested parties. Raw data from neuropsychological testing will only be provided to qualified researchers (e.g. neuropsychologists) to prevent misrepresentation. All other data gathered related to clinical, medical, mental health, and psychosocial histories (sans confidential identifiers) will be made available by the PI or research mentor for future research. The PI and research mentor will assume responsibility for ensuring that participant confidentiality is maintained. Prior to release of data, investigators will need to consent to a VA supported data sharing agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and rTMS+iVCT in people with Mild Cognitive Impairment and Caregiver Burden, run by Central Arkansas Veterans Healthcare System at 1 site in United States.
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 3 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian Moore, PhD (501-257-2152, ian.moore@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hopkins Verbal Leaning Test Standard Score (time frame: baseline, 2 weeks, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.