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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG068317 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TBS | Experimental | Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT). |
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| Sham TBS | Sham Comparator | Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Theta Burst Stimulation | Device | Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80-100% of motor threshold (MT). |
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| Measure | Description | Time Frame |
|---|---|---|
| Verbal recall performance change | Verbal memory will be measured using a free recall task where participants learn a list of everyday words and are asked to recall as many words as they can remember after a period of distraction. Proportion of recollected words will be used to quantify memory performance changes. | Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20. |
| Object recognition memory performance change | Object memory will be measured using an recognition task where participants view photos of everyday objects and are asked to identify them as OLD or NEW during a memory test wherein unseen novel objects and very similar but new photos of identical objects are shown. Recollection and discrimination index will be used to quantify memory performance changes. | Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20. |
| Associative memory performance change | Associative memory will be tested using the Face Name Memory Test wherein participants are shown faces and associated names. Participants are then shown faces only and asked to recall the associated name. | Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting state fMRI functional connectivity | Resting state fMRI activity will be measured before the first and after the last TBS treatment | Baseline (Day 2) before the first treatment and after the last treatment (Day 17) |
| EEG activity |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Hiller | Contact | 310-210-6978 | suthanalab@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Leuchter, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Recruiting | Los Angeles | California | 90024 | United States |
The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication. The results from the proposed project will also be shared at scientific meetings (local, national and international) as well via published manuscripts.
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All data will be provided by the time publication occurs or when the proposed funding period has ended.
Researchers can request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication.
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| Sham Theta Burst Stimulation | Device | Sham stimulation will be delivered at 0-10% of motor threshold (MT), with all other parameters matching the active TBS condition. |
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EEG functional connectivity with stimulated region and medial temporal source localized power in the theta band will be recorded during a resting period as well as during the treatment itself both before and after treatments
| During treatment (Days 3, 7 and 12), after the last treatment (Day 17), and 2 month follow-up session (Day 20) |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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