Brain Stimulation and Cognitive Training for Mild Cognitive Impairment
This study is testing a combination treatment for people with mild cognitive impairment (MCI). It uses accelerated intermittent theta burst stimulation (iTBS), a type of non-invasive brain stimulation, along with computerized cognitive training (CCT) from the BrainHQ platform. All participants will receive iTBS and then be randomly assigned to one of two types of CCT. The study aims to see if this combined treatment is practical and well-received by people aged 60-85, and if it can improve memory, thinking skills, mood, and daily function. You need to have a co-participant (like a spouse or adult child) who can join the study with you.
- Study design
- This is a randomized study with 50 participants. All participants receive active brain stimulation, and then are randomly assigned to one of two types of computerized cognitive training.
- What's involved
- You would have 12 brain stimulation sessions over 3 days within an 8-day period. During breaks, you would complete 11 computerized cognitive training sessions each treatment day. You will also have assessments before treatment and up to 1 month after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed from enrollment until the end of the study at week 6 (1-month post-treatment assessment).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Brain Stimulation and Cognitive Training for MCI
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Stephanie Aghamoosa · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- RetentionFrom enrollment to the end of study at week 6 (1-month post-treatment assessment).
Percent of participants who completed all study procedures(i.e., Week 0 pre-treatment assessments, all treatment sessions, and Week 2 and Week 6 follow-up assessments). This will be calculated as a binary count (1=yes, 0=no) of completers divided by the total number of participants.
- AdherenceOn each of the 3 treatment days during Week 1
Percent of treatment sessions completed. This will be calculated as the number of full iTBS and CCT sessions completed by each participant divided by the prescribed number of sessions.
- AcceptabilityWeek 0 (1 week pre-treatment), Week 2 (1 week post-treatment)
Ratings of treatment acceptability on the Theoretical Framework of Acceptability (TFA) Questionnaire. The TFA is a self-report measure on which participants rate their perceptions of treatment acceptability via 5-point Likert-scale ratings on 8 items regarding the following: affective attitude, burden, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, ethicality, and general acceptability. Item scores will be averaged (ranging from 0-5), with higher scores indicating greater intervention acceptability.
- Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid CompositeWeek 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
The NIHTB-CB is a performance-based, iPad-administered \~30-minute suite of 7 tests that ascertain abilities in different cognitive domains (e.g. executive function, episodic memory, working memory, processing speed, language). It was developed using advanced psychometric techniques to minimize measurement error and produces normed subtest and composite scores. We will use the fully-corrected T-score (range T=0-100; Mean T=50, SD=10; higher scores indicate better cognition) of the Fluid Cognition Composite (normed for age and years of education).
- Change in Preclinical Alzheimer's Cognitive Composite (Mayo-PACC) Z-scoreWeek 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
The Mayo-PACC is a composite derived from a brief battery of three neuropsychological tests of verbal episodic memory, processing speed, and semantic fluency. Z-scores will be computed for each test using a cognitively unimpaired normative reference; these will be averaged to create a single composite Z-score (Mean Z=0, SD=1; higher scores indicate better cognition).