Recruiting

rTMS & VR

Sponsor:

Central Arkansas Veterans Healthcare System

Code:

NCT06024473

Conditions

Mild Cognitive Impairment

Caregiver Burden

Mental Health Issue

ADL

Quality of Life

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

rTMS

rTMS+iVCT

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment

Caregiver Burden

Mental Health Issue

ADL

Quality of Life

Study ID

NCT06024473

Start date

Mar 31, 2024

Status verified date

Feb, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Treatment

This arm will be followed without intervention

active comparator: rTMS

This group will be randomized to receive rTMS treatment

experimental: rTMS+iVCT

This group will be randomized to receive rTMS and iVCT treatment

Interventions

rTMS

Transcranial Magnetic Stimulation

rTMS+iVCT

Transcranial Magnetic Stimulation and immersive virtual reality

Primary outcome measure

  • Change in Hopkins Verbal Leaning Test Standard Score [ Time Frame: baseline, 2 weeks, 3 months ]

Central Contacts and Locations

Central contacts

Locations

Central Arkansas VA Healthcare system

Recruiting

Little Rock, Arkansas, United States, 72114

Contacts

More Information

Sponsor

Central Arkansas Veterans Healthcare System

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Central Arkansas Veterans Healthcare System on 2025-02-20.