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

NCT ID: NCT04558164

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2026-06-30

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.

Conditions

Cognitive Dysfunction; Memory Disorders in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active TBS

Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT).

Group Type: EXPERIMENTAL

Active Theta Burst Stimulation

Intervention Type: DEVICE

Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT).

Sham TBS

Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition.

Group Type: SHAM_COMPARATOR

Sham Theta Burst Stimulation

Intervention Type: DEVICE

Sham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition.

Interventions

Active Theta Burst Stimulation

Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT).

Intervention Type: DEVICE

Sham Theta Burst Stimulation

Sham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Nanthia Suthana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nanthia Suthana

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonja Hiller

Role: CONTACT

suthanalab@mednet.ucla.edu

310-210-6978

Facility Contacts

Sonja Hiller

Role: primary

shiller@mednet.ucla.edu

310-210-6978

Other Identifiers

R01AG068317

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-001417

Identifier Type: -

Identifier Source: org_study_id