RecruitingNot ApplicableNCT06024473

A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI


Sponsor

Central Arkansas Veterans Healthcare System

Enrollment

50 participants

Start Date

Mar 31, 2024

Study Type

INTERVENTIONAL

Conditions

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). 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.


Eligibility

Min Age: 55 Years

Inclusion Criteria3

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

Exclusion Criteria14

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICErTMS

Transcranial Magnetic Stimulation

DEVICErTMS+iVCT

Transcranial Magnetic Stimulation and immersive virtual reality


Locations(1)

Central Arkansas VA Healthcare system

Little Rock, Arkansas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06024473


Related Trials