Clinical trial NCT04558164: Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
Official title: Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Memory Disorders in Old Age
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-09-22
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. The study will enroll MCI subjects and subjects with subjective memory complaints who will be randomly assigned to receive active or sham brain stimulation. 'Blinded' or 'sham-controlled' means that the subject will not know whether the treatment they receive is the active treatment or the non-active stimulation. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating the target brain region.


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.

Primary outcomes:
measure: Verbal recall performance change
timeFrame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
measure: Object recognition memory performance change
timeFrame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
measure: Associative memory performance change
timeFrame: Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.
Secondary outcomes:
measure: Resting state fMRI functional connectivity
timeFrame: Baseline (Day 2) before the first treatment and after the last treatment (Day 17)
measure: EEG activity
timeFrame: During treatment (Days 3, 7 and 12), after the last treatment (Day 17), and 2 month follow-up session (Day 20)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Nanthia Suthana
role: PRINCIPAL_INVESTIGATOR
References: