NCT06024473 · Central Arkansas Veterans Healthcare System
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
(rTMS+iVCT)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
rTMS
Transcranial Magnetic Stimulation
DEVICE
rTMS+iVCT
Transcranial Magnetic Stimulation and immersive virtual reality
Primary outcome measures
Change in Hopkins Verbal Leaning Test Standard Score
Time frame: baseline, 2 weeks, 3 months
range: \<55 to \>130 - higher score is improvement
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- age 55 and over
- previous diagnosis of Mild Cognitive Impairment
- Score of 18 or over on the MoCA during pre-screening procedures.
Exclusion criteria
- 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
- 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
Where
- Little Rock, Arkansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2025 · Source of record for eligibility and locations