A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorCentral Arkansas Veterans Healthcare System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age 55 and over

previous diagnosis of Mild Cognitive Impairment

Score of 18 or over on the MoCA during pre-screening procedures.

Disqualifiers

below 55 years old

Do not pass the TMS Adult Safety Screening

Taking medications known to increase risk of seizure

Taking ototoxic medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Device

    Transcranial Magnetic Stimulation

  • rTMS+iVCT

    Device

    Transcranial Magnetic Stimulation and immersive virtual reality

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Standard TreatmentNo intervention 0 interventions
Group B: rTMSActive comparator 1 intervention
Group C: rTMS+iVCTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hopkins Verbal Leaning Test Standard Score

range: \<55 to \>130 - higher score is improvement

Time frame
baseline, 2 weeks, 3 months

Secondary outcomes

1

Change in NPI

Range: 0-33 Lower score is improvement

Time frame
baseline, 2 weeks, 3 months
2

Change in Functional Activities Questionnaire score

Range: 0-30 Lower score is improvement

Time frame
baseline, 2 weeks, 3 months

Other outcomes

Sponsors and contacts

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