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.
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: * 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that * 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
Changes From Baseline CVLT Scores After Treatment and 4 Month Later
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 After Treatment
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: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Changes in Plasma BDNF Levels After Treatment
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: within a week following the last treatment session and 4 months later
Changes in Animal Fluency After Treatment and 4 Months Later
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
Changes in Trail Making B Test Score After Treatment and 4 Months Later
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up
Brief Visual Memory Test (BVMT)
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
Montreal Cognitive Assessment (MoCA)
MoCA is a one page, 30 point cognitive screening test. It test the following cognitive domains: 1. short-term memory (5 points)- two learning trials of five nouns and delayed recall after approximately five minutes. 2. visuospatial abilities - clock-drawing task (3 points) and copy a cube (1 point). 3. executive functions - alternation task abbreviated trail-making B (1 point), and a two-item verbal abstraction task (2 points). 4. attention, concentration, and working memory - a sustained attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). 5. language - three-item confrontation naming (3 points), repetition of two sentences (2 points), and verbal fluency (1 point). 6. abstract reasoning - describe the similarity of tasks (2 points). 7. orientation to time and place (6 points). Minimum score: 0. Maximum score: 30. Higher the better.
Time frame: Assessed at baseline, end of treatment, and 4-month post-treatment follow up