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

About

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 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
55 Years
Maximum Age
90 Years

Inclusion Criteria:

  • 55-90 years of age
  • Right-handedness
  • Willing to provide informed consent and participate in a longitudinal study
  • In good general health
  • Ability to read, write, and speak English fluently
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Screening laboratory/ECG without abnormalities that might interfere with the study
  • Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria
  • Living independently
  • Subjective memory complaints (self-report and positive score on MFQ)
  • Katz ADL scale: We will exclude potential volunteers scoring < 6
  • Lawton iADL scale: We will exclude potential volunteers scoring < 8 (however, having points off is OK if the volunteer never did a task even prior to memory loss (e.g., more men than women never shopped, did laundry, or cooked due to stereotypical social roles). In such an example, the volunteer could score as low as 5 and still be included (no points off for the three activities never done before memory loss).
  • MMSE score > 24
  • PHQ score > 7
  • Hamilton Depression score < 7
  • No change in use of psychotropic medication for treatment of depression, anxiety, ADHD or psychosis 1 month prior and during the study.
  • At least 1 Standard Deviation below the mean in 2 out of the 3 following tests: BVMT-R (25-minute delay), CVLT-II (20-minute delay), Rey-Osterrieth Complex Figure Task (30-minute delay).

Exclusion Criteria:

  • Diagnosis of dementia
  • Unwilling or unable to provide informed consent
  • Active major psychiatric or neurologic disorders associated with neurocognitive impairment
  • Active or history of alcohol or substance abuse
  • Recent (< 6 months) alcohol or substance abuse excluding nicotine or caffeine
  • Active or history of stroke, 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)
  • Head trauma or systemic diseases affecting brain function
  • Sleep deprivation
  • Uncontrolled hypertension or cardiovascular disease
  • 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.
  • Current enrollment in a memory-enhancement study or course
  • Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain implants or previous abnormal MRI results.

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Study Stats
Protocol No.
20-001417
Category
Semel Institute (Psychiatry)
Principal Investigator
Nanthia Suthana
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04558164
For detailed technical eligibility, visit ClinicalTrials.gov.