A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI (rTMS+iVCT)

February 19, 2025 updated by: Central Arkansas Veterans Healthcare System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this pilot study is to assess if combined treatment with repetitive transcranial magnetic stimulation (rTMS) and immersive virtual reality mediated cognitive training program (iVCT) improves cognitive, emotional, and functional abilities in participants with mild cognitive impairment (MCI) compared to usual care. Secondary objective of the study is assess if rTMS+iVCT treatment improves caregiver burden.

Older Veterans (N=50) age ≥ 55 years with mild cognitive impairment will be recruited. All participants will be screened for suitability for the rTMS and iVCT treatments. Those eligible (N=30) will complete a baseline assessment of their cognitive, emotional, and functional abilities and caregiver burden (Visit 1). Participants (N=30) will be randomly assigned to a rTMS group, rTMS+iVCT group, and control group.. Participants in the rTMS group will receive rTMS treatment daily for 5 days of the week for 2 weeks. Participants in the rTMS+iVCT group will receive rTMS treatment followed by 30-60 minutes of iVCT intervention daily for 5 days of the week for 2 weeks. Participants in the control group will receive usual care. All testing will be repeated posttreatment at 2 weeks (Visit 2) and at 3 months(Visit 3) .

Innovations include combination of two non-pharmacological interventions and the inclusion of 3-month post-treatment testing to assess the durability of changes. Feedback will be gathered to improve the treatment program. Assuming positive findings, this research will help establish a new treatment modality for improving the cognitive, emotional, and functional abilities in MCI.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rTMS
This group will be randomized to receive rTMS treatment
Device: rTMS
Transcranial Magnetic Stimulation
No Intervention: Standard Treatment
This arm will be followed without intervention
Experimental: rTMS+iVCT
This group will be randomized to receive rTMS and iVCT treatment
Device: rTMS+iVCT
Transcranial Magnetic Stimulation and immersive virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hopkins Verbal Leaning Test Standard Score
Time Frame: baseline, 2 weeks, 3 months
range: <55 to >130 - higher score is improvement
baseline, 2 weeks, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NPI
Time Frame: baseline, 2 weeks, 3 months
Range: 0-33 Lower score is improvement
baseline, 2 weeks, 3 months
Change in Functional Activities Questionnaire score
Time Frame: baseline, 2 weeks, 3 months
Range: 0-30 Lower score is improvement
baseline, 2 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

March 31, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1762307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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