Using brain stimulation to improve memory in people with mild cognitive impairment
A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI)
NA · Mayo Clinic · NCT05327257
This study is testing if a new type of brain stimulation can help improve memory in adults with mild cognitive impairment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05327257 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the feasibility of administering intermittent theta burst stimulation (iTBS) repetitive transcranial magnetic stimulation (rTMS) in adults diagnosed with mild cognitive impairment (MCI). The study will employ a cross-over design, where participants will undergo two 10-day treatment periods of iTBS rTMS targeting different brain regions. Assessments will include neuropsychological tests, functional brain imaging, and questionnaires at multiple time points to measure the effects on memory and cognitive functions. The goal is to gather pilot data on the efficacy of this treatment protocol in enhancing cognitive abilities in individuals with MCI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with mild cognitive impairment who meet specific cognitive and health criteria.
Not a fit: Patients with advanced dementia or those who do not meet the criteria for mild cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved memory and cognitive function in patients with mild cognitive impairment.
How similar studies have performed: Other studies have shown promise with similar brain stimulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Must speak English fluently * Diagnosis of MCI as defined by: * Clinical diagnosis by a neurologist * Neuropsychological testing support of MCI * Meet criteria for MCI * Subjective cognitive decline reported by participant and/or an informant * Objective memory impairment in one or more cognitive domains for age * Essentially preserved general cognitive function * Largely intact functional activities * Does not meet criteria for dementia as judged by a clinician * Eligible for transcranial magnetic stimulation (TMS) based on safety criteria * Clinical Dementia Rating=0.5 * Geriatric Depression Scale score less than 6 * Medically stable and in good general health * Not pregnant, lactating, or of childbearing potential * Stable medication regimen for at least 4 weeks prior to baseline visit * Adequate visual and auditory abilities to complete neuropsychological testing * Ability to provide informed consent * Have a care partner who is available to accompany the participant to study visits for the duration of the protocol. Exclusion Criteria * Inability to communicate in the English language * Meet criteria for dementia * Contraindications to TMS or MRI, including patients who have * conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or jewelry) * active or inactive implants, including deep brain stimulators, cochlear implants, vagus nerve stimulators or implanted device leads * Any true positive findings on the TMS safety screening form * Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within the past 12 months * History of epilepsy or seizures * Medical conditions that increase risk of seizures * History of traumatic brain injury * History of intracranial mass or lesion * History of stroke, including hemorrhagic stroke and ischemic stroke * Psychiatric disorders * Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform disorder), any history * Primary mood disorder (major depressive disorder, bipolar disorder) within the past 12 months * Substance use disorder (except caffeine and nicotine) within the past 12 months * Active symptoms of depression, anxiety, mania, psychosis, or substance use (except caffeine and nicotine) within the past year * Active symptoms of depression will be identified based on geriatric depression scale ≥ 6 * Other active symptoms of psychiatric conditions to be determined by study investigators * Sleep disorders that are considered clinically significant and not sufficiently treated by the investigative team, including untreated obstructive sleep apnea (apnea-hypopnea index \>15), untreated/suboptimally treated REM sleep behavior disorder, untreated/suboptimally treated restless legs syndrome * Pregnancy or suspected pregnancy * Participation in another concurrent interventional clinical trial * Any unstable medical condition * Inability to provide informed consent * Inability to adhere to the protocol
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Maria I Lapid — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, Transcranial Magnetic Stimulation