Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-24
Brief Title:
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Sponsor:
Central Arkansas Veterans Healthcare System
Organization:
Central Arkansas Veterans Healthcare System
Study Overview
Official Title:
A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rTMSiVCT
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 rTMSiVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups
Examine if rTMSiVCT intervention improves participants mental health symptoms functional abilities and quality of life more than control or rTMS only groups
Examine the impact of rTMSiVCT intervention on caregiver burden
Eligible participants will be assigned to a standard treatment no intervention control group rTMS only group of rTMSiVCT 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 rTMSiVCT 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
Examine if rTMSiVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups
Examine if rTMSiVCT intervention improves participants mental health symptoms functional abilities and quality of life more than control or rTMS only groups
Examine the impact of rTMSiVCT intervention on caregiver burden
Eligible participants will be assigned to a standard treatment no intervention control group rTMS only group of rTMSiVCT 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 rTMSiVCT 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 rTMSiVCT treatment improves caregiver burden
Older Veterans N50 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 N30 will complete a baseline assessment of their cognitive emotional and functional abilities and caregiver burden Visit 1 Participants N30 will be randomly assigned to a rTMS group rTMSiVCT 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 rTMSiVCT 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 monthsVisit 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
Older Veterans N50 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 N30 will complete a baseline assessment of their cognitive emotional and functional abilities and caregiver burden Visit 1 Participants N30 will be randomly assigned to a rTMS group rTMSiVCT 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 rTMSiVCT 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 monthsVisit 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None