Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Sep 15, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring whether a special type of brain stimulation can help improve memory in older adults who have mild cognitive impairment (MCI) or memory issues. Researchers will use a device called transcranial magnetic stimulation (TMS) to gently stimulate a part of the brain that is important for memory. Participants will be randomly assigned to receive either the active stimulation or a non-active version (called "sham"), so they won't know which one they are getting. This helps ensure the results are accurate.

To participate in this study, individuals need to be between 55 and 100 years old, right-handed, and in good health, living independently, with self-reported memory complaints. They should also be able to speak, read, and write in English. Participants will undergo some initial tests to ensure they qualify and will be asked to provide consent for their involvement. During the trial, they can expect to receive brain stimulation treatments and take part in assessments to track any changes in their memory. It’s important to note that those with a diagnosis of dementia or certain other medical conditions will not be eligible.

Gender

ALL

Eligibility 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.