A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

Recruiting now · Not applicable

Conditions studied: Mild Cognitive Impairment, Caregiver Burden, Mental Health Issue, ADL, Quality of Life

In brief

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.

Key facts

Study ID

NCT06024473

Run by

Central Arkansas Veterans Healthcare System

People needed

50

Starts

2024-03-31

Expected to finish

2026-09-01

Last updated by the study team

2025-02-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 55 and over
• previous diagnosis of Mild Cognitive Impairment
• Score of 18 or over on the MoCA during pre-screening procedures.

You may not qualify if…

• 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 it is running

• Central Arkansas VA Healthcare system — Little Rock, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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