A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
rTMS+iVCT
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedStudy Start
First participant enrolled
March 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedFebruary 20, 2025
February 1, 2025
2 years
August 24, 2023
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Hopkins Verbal Leaning Test Standard Score
range: \<55 to \>130 - higher score is improvement
baseline, 2 weeks, 3 months
Secondary Outcomes (2)
Change in NPI
baseline, 2 weeks, 3 months
Change in Functional Activities Questionnaire score
baseline, 2 weeks, 3 months
Study Arms (3)
Standard Treatment
NO INTERVENTIONThis arm will be followed without intervention
rTMS
ACTIVE COMPARATORThis group will be randomized to receive rTMS treatment
rTMS+iVCT
EXPERIMENTALThis group will be randomized to receive rTMS and iVCT treatment
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Arkansas VA Healthcare system
Little Rock, Arkansas, 72114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open label pilot study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2023
First Posted
September 6, 2023
Study Start
March 31, 2024
Primary Completion
March 31, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share
To ensure participant confidentiality, the database will not be made available for public access. One year post completion of the funded study or upon acceptance of the data for publication, deidentified data will be made available to interested parties. Raw data from neuropsychological testing will only be provided to qualified researchers (e.g. neuropsychologists) to prevent misrepresentation. All other data gathered related to clinical, medical, mental health, and psychosocial histories (sans confidential identifiers) will be made available by the PI or research mentor for future research. The PI and research mentor will assume responsibility for ensuring that participant confidentiality is maintained. Prior to release of data, investigators will need to consent to a VA supported data sharing agreement.