An interventional study of Accelerated iTBS and Computerized Cognitive Training in Mild Cognitive Impairment (MCI), Mild Neurocognitive Disorder and Neurocognitive Disorders, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
This is a randomized clinical trial of a treatment that combines non-invasive brain stimulation with computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The form of brain stimulation used in this study is accelerated intermittent theta burst stimulation (iTBS). All participants receive the same amount of iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the study are to see if this combined treatment is feasible and acceptable to people with MCI and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily function.
This is a randomized, sham-controlled trial of combined intermittent theta burst stimulation (iTBS) and computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The primary objectives of this study are to determine the feasibility, acceptability, and preliminary effect sizes of 3-day combined iTBS+CCT for improving neurocognitive and psychosocial function in MCI.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 50 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets the following requirements for current and prior medications and treatments:
Anti-amyloid monoclonal antibody therapy for AD/MCI:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 12 sessions of accelerated iTBS and 11 sessions of active CCT on each of 3 treatment days.
Device: Accelerated iTBS · Device: Computerized Cognitive Training
Participants will receive 12 sessions of accelerated iTBS and 11 sessions of sham CCT on each of 3 treatment days.
Device: Accelerated iTBS · Device: Sham Computerized Cognitive Training
A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System with Brainsight neuronavigation will be used. All participants will receive active treatment: 12 sessions (3 min each) of iTBS on each of 3 treatment days within an 8-day span. A single session = 600 pulses of 50 Hz iTBS triplets delivered every 200ms in 2s trains repeated every 10s (8s inter-train interval) for 190s. Stimulation intensity is 120% resting motor threshold (rMT) delivered at the left dorsolateral prefrontal cortex. Total pulses = 21,600. Inter-session intervals will be approx. 15 min.
CCT will be delivered through the online BrainHQ platform. Participants will engage in adaptive visual speed of processing training during the 15-min breaks between iTBS sessions (11 sessions on each treatment day, total CCT time = 495 min).
Sham CCT will be delivered through the online BrainHQ platform. Participants will engage in non-adaptive control games during the 15-min breaks between iTBS sessions (11 sessions on each treatment day, total sham CCT time = 495 min).
Retention
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.
Time frame: From enrollment to the end of study at week 6 (1-month post-treatment assessment).
Adherence
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.
Time frame: On each of the 3 treatment days during Week 1
Acceptability
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.
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment)
Change in NIH Toolbox-Cognition Battery (NIHTB-CB) Fluid Composite
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).
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Change in Preclinical Alzheimer's Cognitive Composite (Mayo-PACC) Z-score
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).
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Change in Quick Dementia Rating System (QDRS) Total Score
The QDRS is an informant-rated measure used to evaluate changes in participants' memory, orientation, and functional abilities on a 5-point scale (0, 0.5, 1, 2, 3). Item scores are summed, and higher scores suggest greater impairment.
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Change in Informant-rated Everyday Cognition (ECog-II) Scale Total Score
The ECog-II scale is an informant-rated questionnaire of change in participants' everyday cognitive and functional abilities in six domains: memory, language, visuospatial function, and executive function. Each item is scored on a 4-point scale (0-"Better or no change", 1-"Questionable/occasionally worse", 2-"Consistently a little worse", 3-"Consistently much worse"). Each item also has an "I don't know" response option, which does not contribute to their score. Item scores will be averaged (range: 0-3), with higher scores indicating greater impairment.
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Change in PROMIS Cognitive Function, Depression, Anxiety, Sleep Disturbance, and Fatigue T-scores
These are self-report questionnaires to which respondents rate their perceived (i.e., subjective) cognitive abilities and symptoms (i.e., depression, anxiety, fatigue, sleep disturbance) on a 5-point scale (from 1-"Not at all"; "Never" to 5-"Very much"; "Always", respectively) during the specified timeframe. It is a computer adaptive test given as a REDCap survey that yields normed T-scores (range T=0-100; Mean T=50, SD=10). Higher scores indicate more of the respective symptom.
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Plan to share: Yes — De-identified data and MRI images will be shared via OpenNeuro and with approved researchers per NIH data sharing policies.
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