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New treatment option for Mild Cognitive Impairment (MCI)
Official title Brain Stimulation and Cognitive Training for MCI
ClinicalTrials.gov ID: NCT07526740
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- 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...
- Meets the following requirements for current and prior medications and treatments:
You likely can't join if
- 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...
- 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)...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.