Clinical trial NCT06024473: A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Official title: A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Central Arkansas Veterans Healthcare System
Sponsor class: FED
First posted: 2023-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Hopkins Verbal Leaning Test Standard Score
timeFrame: baseline, 2 weeks, 3 months
Secondary outcomes:
measure: Change in NPI
timeFrame: baseline, 2 weeks, 3 months
measure: Change in Functional Activities Questionnaire score
timeFrame: baseline, 2 weeks, 3 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas VA Healthcare system
state: Arkansas
Study officials:
References: