A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
NCT ID: NCT06024473
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-31
2026-09-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Treatment
This arm will be followed without intervention
No interventions assigned to this group
rTMS
This group will be randomized to receive rTMS treatment
rTMS
Transcranial Magnetic Stimulation
rTMS+iVCT
This group will be randomized to receive rTMS and iVCT treatment
rTMS+iVCT
Transcranial Magnetic Stimulation and immersive virtual reality
Interventions
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rTMS
Transcranial Magnetic Stimulation
rTMS+iVCT
Transcranial Magnetic Stimulation and immersive virtual reality
Eligibility Criteria
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Inclusion Criteria
* previous diagnosis of Mild Cognitive Impairment
* Score of 18 or over on the MoCA during pre-screening procedures.
Exclusion Criteria
* 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
* 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
55 Years
ALL
Yes
Sponsors
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Central Arkansas Veterans Healthcare System
FED
Responsible Party
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Locations
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Central Arkansas VA Healthcare system
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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1762307
Identifier Type: -
Identifier Source: org_study_id
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