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

Primary Purpose

Mild Cognitive Impairment, Caregiver Burden, Mental Health Issue

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS
rTMS+iVCT
Sponsored by
Central Arkansas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring repetitive Transcranial Magnetic Stimulation, immersive virtual reality, Neuropsychiatric Symptoms, Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central Arkansas VA Healthcare system

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Standard Treatment

rTMS

rTMS+iVCT

Arm Description

This arm will be followed without intervention

This group will be randomized to receive rTMS treatment

This group will be randomized to receive rTMS and iVCT treatment

Outcomes

Primary Outcome Measures

Change in Hopkins Verbal Leaning Test Standard Score
range: <55 to >130 - higher score is improvement

Secondary Outcome Measures

Change in NPI
Range: 0-33 Lower score is improvement
Change in Functional Activities Questionnaire score
Range: 0-30 Lower score is improvement

Full Information

First Posted
August 24, 2023
Last Updated
September 5, 2023
Sponsor
Central Arkansas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT06024473
Brief Title
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Acronym
rTMS+iVCT
Official Title
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Arkansas Veterans Healthcare System

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Caregiver Burden, Mental Health Issue, ADL, Quality of Life
Keywords
repetitive Transcranial Magnetic Stimulation, immersive virtual reality, Neuropsychiatric Symptoms, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups
Masking
None (Open Label)
Masking Description
This is an open label pilot study
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Treatment
Arm Type
No Intervention
Arm Description
This arm will be followed without intervention
Arm Title
rTMS
Arm Type
Active Comparator
Arm Description
This group will be randomized to receive rTMS treatment
Arm Title
rTMS+iVCT
Arm Type
Experimental
Arm Description
This group will be randomized to receive rTMS and iVCT treatment
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
rTMS+iVCT
Intervention Description
Transcranial Magnetic Stimulation and immersive virtual reality
Primary Outcome Measure Information:
Title
Change in Hopkins Verbal Leaning Test Standard Score
Description
range: <55 to >130 - higher score is improvement
Time Frame
baseline, 2 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in NPI
Description
Range: 0-33 Lower score is improvement
Time Frame
baseline, 2 weeks, 3 months
Title
Change in Functional Activities Questionnaire score
Description
Range: 0-30 Lower score is improvement
Time Frame
baseline, 2 weeks, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Moore, PhD
Phone
501-257-2152
Email
ian.moore@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Lasi McGhee
Phone
(501) 257-2521
Email
lasi.mcghee@va.gov
Facility Information:
Facility Name
Central Arkansas VA Healthcare system
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Moore, PhD
Phone
501-257-2152
Email
ian.moore@va.gov
First Name & Middle Initial & Last Name & Degree
Lasi McGhee, BS
Phone
(501) 257-2521
Email
lasi.mcghee@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

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