VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207, United States
NCT Number: NCT02621424
The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.
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Notify Me55 year–99 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94304-1207, United States
The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
stimulation of the brain with magnetic pulses
sham noise to block the sound of stimulation
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes of California verbal learning test scores (CVLT) from baseline after treatment and 4 months later.
CVLT is 16 points scoring system. (minimum=0, maximum=16, higher the better memory).
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes in Boston Naming Test (BNT) from baseline was analyzed. BNT is a 60 points scoring system. (minimum=0, maximum=60, higher the better).
Time frame: within a week following the last treatment session and 4 months later
Changes in BDNF plasma levels (pg/ml) from baseline were analyzed after treatment.
BDNF is a plasma biomarker, minimum=0, no maximum. Higher number means more BDNF synthesis).
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Animal Fluency (AF) is a scoring system to assess the ability to generate a list of related words.
The score is the number of animals the examinee can name in one minute time. (Minimum = 0, No maximum, higher the better).
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Trail making B is a scoring system for the assessment of the mental flexibility, processing speed and executive function. The score is the time (in seconds) it takes for the examinee to draw line segments connecting sequentially from 1-A-2-B-3....all the way to12-L-13. (The lower score means faster speed and means better performance. The minimum is (hypothetically) zero. There is no maximum. However, in some test centers, the maximum allowed time is 200 seconds.
Time frame: assessed at baseline, end of treatment and 4-month post-treatment follow up
A piece of paper with 6 simple drawings is presented to the subject for 10 seconds. The subject is then asked to draw these drawings from memory. The process is repeated three times to assess visual memory and learning. Each correct drawing scores two pints. Maximum score for three trials is 36. Minimum score is 0. Higher the better.
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains:
VA Office of Research and Development
Fed
Acronym: rTMS for demen
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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