Mild Cognitive Impairment (MCI)RISE pilotNCT07526740
Brain Stimulation and Cognitive Training for MCI
A study testing Accelerated iTBS and Computerized Cognitive Training in people with Mild Cognitive Impairment (MCI) and Mild Neurocognitive Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Mild Neurocognitive Disorder, Neurocognitive Disorders
- What is being tested?
- Accelerated iTBS and Computerized Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-85 (inclusive).
- English as a first/primary language.
- Adequate sensorimotor function and verbal expressive abilities to complete all assessments.
- Must have a co-participant (e.g. spouse, adult child or relative, sibling, cohabitator, friend, caregiver) who has at least weekly in-person contact with the participant and is willing to participate in the study as a collateral informant.
- Meets the following requirements for current and prior medications and treatments:
- Is on fixed pharmacotherapy (i.e. stable dose of medication/s) for ≥ 4 weeks before enrollment. This includes, but is not limited to, cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants.
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- Anti-amyloid monoclonal antibody therapy for AD/MCI:
- Prior treatment is permitted if last infusion occurred ≥ 8 weeks before enrollment.
- Current treatment is permitted if the dose has been stable for ≥ 12 weeks before enrollment, with no planned dose change during study participation.
- Prior TMS treatment is permitted if the last stimulation session was ≥ 24 weeks before enrollment.
- Documented diagnosis of MCI per NIA-AA criteria or Mild Neurocognitive Disorder per DSM-5 criteria by a healthcare provider within the past year, with a presumed etiology of possible or probable AD 7. Met actuarial neuropsychological criteria for MCI43 within the past year (i.e. ≥2 impaired scores within one cognitive domain, or ≥1 impaired scores in ≥3 domains, where an impaired score is defined as ≤16th percentile using appropriate demographically-corrected norms).
Who cannot join
- Telephone Interview for Cognitive Status (TICS) score of ≤ 22 suggestive of dementia.
- Prior diagnosis of Dementia (NIA-AA) or Major Neurocognitive Disorder (DSM-5).
- Daily/weekly anticholinergic or sedative use. Stimulants may be allowed pending investigator review.
- History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), severe mental illness (e.g., bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury, seizures).
- Plan to initiate treatment for AD/MCI with monoclonal antibody therapy during study participation.
- For those currently receiving monoclonal antibody therapy, documented history of clinically significant amyloid-related imaging abnormalities (ARIA) in their medical record.
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- Current use of any implanted brain stimulation device.
- Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days that may impact cognition or mood.
- MRI contraindications (e.g., ferromagnetic implants, claustrophobia).
- Unable or unwilling to engage in BrainHQ activities.
- TMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking medications that have short half-lives) or no identifiable motor threshold.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Kaitlin Cox, 843-608-1674
About this study
Official title: Combining Brain Stimulation With Computerized Cognitive Training for MCI
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI), Mild Neurocognitive Disorder, Neurocognitive Disorders, Cognitive Dysfunction, Cognition Disorders
- Being tested
- Accelerated iTBS, Computerized Cognitive Training, Sham Computerized Cognitive Training
- Keywords
- Aging, Alzheimers, Memory Loss, Mild Cognitive Impairment, Transcranial Magnetic Stimulation, cognitive training
- Medical subject headings
- Cognitive Dysfunction, Neurocognitive Disorders, Cognition Disorders, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated iTBSDevice
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.
Computerized Cognitive TrainingDevice
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 Computerized Cognitive TrainingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| iTBS+CCT | Experimental | Participants will receive 12 sessions of accelerated iTBS and 11 sessions of active CCT on each of 3 treatment days. Receives: Device: Accelerated iTBS; Device: Computerized Cognitive Training |
| iTBS+shamCCT | Sham comparator | Participants will receive 12 sessions of accelerated iTBS and 11 sessions of sham CCT on each of 3 treatment days. Receives: Device: Accelerated iTBS; Device: Sham Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start16 Mar 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be randomized after W0 (pre-treatment assessments) to either active or sham CCT. A random permuted block design (block sizes of 2 and 4) will be used to ensure equal sample sizes of the two groups, with an allocation ratio of 1:1 and stratification by monoclonal antibody (mAB) treatment (i.e., naïve vs. treated, where "treated" refers to either prior or current treatment) to ensure balance across groups in this covariate. All participants will receive the same number of CCT and iTBS sessions per day irrespective of group they are assigned.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stephanie Aghamoosa, Medical University of South Carolina
- Investigators
- Stephanie Aghamoosa, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526740
- Sponsor's protocol ID
- Pro00138352
- Other IDs
- 1K23AG090691-01
- Acronym
- RISE pilot
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data and MRI images will be shared via OpenNeuro and with approved researchers per NIH data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Brain Stimulation With Computerized Cognitive Training for MCI
- ClinicalTrials.gov ID
- NCT07526740
- Acronym / sponsor ID
- RISE pilot / Pro00138352
- Conditions
- Mild Cognitive Impairment (MCI), Mild Neurocognitive Disorder, Neurocognitive Disorders, Cognitive Dysfunction, Cognition Disorders
- Keywords
- Aging, Alzheimers, Memory Loss, Mild Cognitive Impairment, Transcranial Magnetic Stimulation, cognitive training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomized after W0 (pre-treatment assessments) to either active or sham CCT. A random permuted block design (block sizes of 2 and 4) will be used to ensure equal sample sizes of the two groups, with an allocation ratio of 1:1 and stratification by monoclonal antibody (mAB) treatment (i.e., naïve vs. treated, where "treated" refers to either prior or current treatment) to ensure balance across groups in this covariate. All participants will receive the same number of CCT and iTBS sessions per day irrespective of group they are assigned.
| Arm | Type | Receives |
|---|---|---|
| iTBS+CCT | Experimental | Device: Accelerated iTBS, Device: Computerized Cognitive TrainingParticipants will receive 12 sessions of accelerated iTBS and 11 sessions of active CCT on each of 3 treatment days. |
| iTBS+shamCCT | Sham comparator | Device: Accelerated iTBS, Device: Sham Computerized Cognitive TrainingParticipants will receive 12 sessions of accelerated iTBS and 11 sessions of sham CCT on each of 3 treatment days. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 60-85 (inclusive).
- English as a first/primary language.
- Adequate sensorimotor function and verbal expressive abilities to complete all assessments.
- Must have a co-participant (e.g. spouse, adult child or relative, sibling, cohabitator, friend, caregiver) who has at least weekly in-person contact with the participant and is willing to participate in the study as a collateral informant.
- Meets the following requirements for current and prior medications and treatments:
Key exclusion criteria (11 listed)
- Telephone Interview for Cognitive Status (TICS) score of ≤ 22 suggestive of dementia.
- Prior diagnosis of Dementia (NIA-AA) or Major Neurocognitive Disorder (DSM-5).
- Daily/weekly anticholinergic or sedative use. Stimulants may be allowed pending investigator review.
- History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), severe mental illness (e.g., bipolar disorder, psychoses), alcohol or substance use disorder, developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury, seizures).
- Plan to initiate treatment for AD/MCI with monoclonal antibody therapy during study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated iTBSA 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. | Device | iTBS+CCT, iTBS+shamCCT |
| Computerized Cognitive TrainingCCT 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). | Device | iTBS+CCT |
| Sham Computerized Cognitive TrainingSham 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). | Device | iTBS+shamCCT |
Primary outcome
Retention
Time frame: From 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.
Adherence
Time frame: On 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.
Acceptability
Time frame: Week 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 Composite
Time frame: Week 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-score
Time frame: Week 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).
2 secondary outcomes
Change in Quick Dementia Rating System (QDRS) Total Score
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
Time frame: Week 0 (1 week pre-treatment), Week 2 (1 week post-treatment), and Week 6 (4 weeks post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Aghamoosa principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated iTBS and Computerized Cognitive Training in people with Mild Cognitive Impairment (MCI) and Mild Neurocognitive Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin Cox (843-608-1674, coxkai@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: From enrollment to the end of study at week 6 (1-month post-treatment assessment).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.