RECRUITING

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

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Conditions

Cognitive DysfunctionMemory Disorders in Old Age

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-26
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04558164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Agreement to participate in the study
  2. * 55-100 years of age
  3. * Right-handedness
  4. * In good general health
  5. * Living independently
  6. * Subjective memory complaints (self-report and positive score on MFQ)
  7. * 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.
  8. * MMSE score \> 24
  9. * PHQ Depression score =\< 7
  10. * Ability to read, write, and speak English fluently
  11. * 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.
  12. * No change in use of psychotropic medication for treatment of depression, anxiety, ADHS or psychosis 1 month prior and during the study.
  1. * Unwilling or unable to provide informed consent
  2. * Diagnosis of dementia
  3. * Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment
  4. * History of alcohol or substance abuse
  5. * Recent (\< 6 months) alcohol or substance abuse (excluding nicotine or caffeine)
  6. * 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)
  7. * Non-English speaking participants
  8. * Not right handed based on self-report or evaluation based on a standard report
  9. * Has received TMS before (not TMS naïve)
  10. * Poorly controlled hypertension or cardiovascular disease
  11. * Current enrollment in a memory-enhancement study or course
  12. * Contraindication to TMS or MRI including claustrophobia, metal in body, surgery within 60 days, certain implants, or previous abnormal MRI results.
  13. * scanning facial tattoos is okay if safe with MRI
  14. * is taking:
  15. * anticholinergic medication (e.g., Detrol, Cogentin);
  16. * sedating antihistamine (e.g., Benadryl);
  17. * any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron).
  18. * benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.

Contacts and Locations

Study Contact

Sonja Hiller
CONTACT
310-210-6978
suthanalab@mednet.ucla.edu

Principal Investigator

Nanthia Suthana
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90024
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Nanthia Suthana, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-26
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-01-26
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cognitive Dysfunction
  • Memory Disorders in Old Age