Brain stimulation to improve memory in older adults with mild cognitive impairment
Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
This study is testing if a special type of brain stimulation can help older adults with mild memory problems improve their memory.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04558164 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial magnetic stimulation on memory improvement in older adults with mild cognitive impairment (MCI) and subjective memory complaints. Participants will be randomly assigned to receive either active or sham stimulation, ensuring that neither the participants nor the researchers know which treatment is being administered. The goal is to determine if targeted brain stimulation can enhance memory function in this population.
Who should consider this trial
Good fit: Ideal candidates are right-handed individuals aged 55-100 with subjective memory complaints and a diagnosis of mild neurocognitive disorder.
Not a fit: Patients with significant impairment in daily living activities or those with severe cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new non-invasive treatments for improving memory in individuals with mild cognitive impairment.
How similar studies have performed: Other studies using brain stimulation techniques have shown promise in improving cognitive functions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Agreement to participate in the study * 55-100 years of age * Right-handedness * In good general health * Living independently * Subjective memory complaints (self-report and positive score on MFQ) * Katz ADL scale and Lawton iADL scale: We will review scores on a case-by-case basis if they did not score 100%. We will exclude if the scores show impairment in ADLs that suggests problems with independent functioning due to cognitive impairment. * MMSE score \> 24 * PHQ Depression score =\< 7 * Ability to read, write, and speak English fluently * Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria. Participants with subjective memory complaints without an aMCI diagnosis will be reviewed on a case-by-case basis based on neuropsychological scores. Participants scoring a raw score of 0 or 3 standard deviations below normative expectations on the long delay recall in two or more of the three tasks (BVMT-R, RCFT, and CVLT-III) will be excluded. * No change in use of psychotropic medication for treatment of depression, anxiety, ADHS or psychosis 1 month prior and during the study. Screening diagnostic criteria for aMCI will be subjective memory complaints, intact instrumental and basic activities of daily living (Smith et al., 1996), PHQ, MMSE, BVMT-R (25-minute delay), CVLT-II (20-minute delay), Rey-Osterrieth Complex Figure Task (30-minute delay). Baseline assessments will include neuropsychological testing of all study subjects. Exclusion Criteria: * Unwilling or unable to provide informed consent * Diagnosis of dementia * Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment * History of alcohol or substance abuse * Recent (\< 6 months) alcohol or substance abuse (excluding nicotine or caffeine) * History of stroke (if the stroke in our judgment is related to the memory problem), traumatic brain injury with loss of consciousness, or other neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease) * Non-English speaking participants * Not right handed based on self-report or evaluation based on a standard report * Has received TMS before (not TMS naïve) * Poorly controlled hypertension or cardiovascular disease * Current enrollment in a memory-enhancement study or course * Contraindication to TMS or MRI including claustrophobia, metal in body, surgery within 60 days, certain implants, or previous abnormal MRI results. * scanning facial tattoos is okay if safe with MRI * is taking: * anticholinergic medication (e.g., Detrol, Cogentin); * sedating antihistamine (e.g., Benadryl); * any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron). * benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.
Where this trial is running
Los Angeles, California
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Leuchter, MD — University of California, Los Angeles
- Study coordinator: Sonja Hiller
- Email: suthanalab@mednet.ucla.edu
- Phone: 310-210-6978
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.