RECRUITING

A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

Quick Facts

Study Start:2024-03-31
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06024473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 55 and over
  2. * previous diagnosis of Mild Cognitive Impairment
  3. * Score of 18 or over on the MoCA during pre-screening procedures.
  1. * below 55 years old
  2. * Do not pass the TMS Adult Safety Screening
  3. * Taking medications known to increase risk of seizure
  4. * Taking ototoxic medications
  5. * Those with implanted device
  6. * History of bipolar disorder
  7. * History of Tourette's syndrome or presence of motor tics
  8. * History of seizures/ seizures in first degree relatives
  9. * History of stroke, aneurysm, or cranial neurosurgery
  10. * Current alcohol related disorder needing medical treatment
  11. * History of abnormal electroencephalogram (EEG)
  12. * History of motion sickness, nausea, vomiting, seizures, or migraine
  13. * Significant balance/gait impairments/history of falls
  14. * History of hyperacusis or photophobia

Contacts and Locations

Study Contact

Ian Moore, PhD
CONTACT
501-257-2152
ian.moore@va.gov

Study Locations (Sites)

Central Arkansas VA Healthcare system
Little Rock, Arkansas, 72114
United States

Collaborators and Investigators

Sponsor: Central Arkansas Veterans Healthcare System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-31
Study Completion Date2026-09

Study Record Updates

Study Start Date2024-03-31
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • repetitive Transcranial Magnetic Stimulation
  • immersive virtual reality
  • Neuropsychiatric Symptoms
  • Mild Cognitive Impairment

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Caregiver Burden
  • Mental Health Issue
  • ADL
  • Quality of Life