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NCT03331796

Noninvasive Brain Stimulation for Mild Cognitive Impairment

Completed NA Results posted Last updated 3 September 2025
What this trial tests

NA trial testing Active rTMS (Bilateral DLPFC) in Mild Cognitive Impairment in 69 participants. Completed in 28 March 2023.

Timeline
15 June 2018
Primary endpoint
19 December 2022
28 March 2023

Quick facts

Lead sponsorPalo Alto Veterans Institute for Research
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment69
Start date15 June 2018
Primary completion19 December 2022
Estimated completion28 March 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Palo Alto Veterans Institute for Research

Who can join

Adults 55 to 90, any sex, with Mild Cognitive Impairment or Mild Neurocognitive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Words Correctly Recalled, List Learning, California Verbal Learning Test-II, Assessed 1 Week After Intervention and Adjusted for Baseline Performance Primary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. The total number of words correctly recalled on the 5 list-learning trials was computed (range = 0 to 80). Higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)36.1± 11.0
Active rTMS (Bilateral LPC)48.8± 8.7
Placebo rTMS (Inactive)37.0± 11.4
Total Number of Words Correctly Recalled, List Learning, California Verbal Learning Test-II, Assessed 3 Months After Intervention and Adjusted for Baseline Performance Secondary · 3 months after completing the 20-session intervention (acceptable window for assessment: 76-104 days after the final intervention session)

The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. The total number of words correctly recalled on the 5 list-learning trials was computed (range = 0 to 80). Higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)38.4± 10.3
Active rTMS (Bilateral LPC)53.0± 14.3
Placebo rTMS (Inactive)41.3± 6.9
California Verbal Learning Test-II (CVLT-II) Semantic Clustering Score, 1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of 16 semantically related words and remember the list after a delay interval. There are 5 orally presented learning trials; each is followed by immediate recall of the words in any order. A measure of semantic clustering is calculated by a computer program. It is a measure of the participant's tendency to recall words in semantically organized clusters (e.g. the participant recalled "apple" and "orange" even though the two fruit words were not presented se

GroupValue95% CI
Active rTMS (Bilateral DLPFC)0.5± 1.0
Active rTMS (Bilateral LPC)0.5± 1.2
Placebo rTMS (Inactive)0.1± 0.6
Total Number of Words Correctly Recalled During the "Long Delay Free Recall" Component of the California Verbal Learning Test-II (CVLT-II), Assessed 1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention

The California Verbal Learning Test, Second edition (CVLT-II) is a memory task that yields several indices of the ability to learn a list of semantically related words and remember the list after a delay interval. The target list ("List A") of the CVLT-II contains 16 words. After 5 learning trials and a subsequent 20-minute delay filled with unrelated tests, the participant was asked to recall the 16-word target list of the CVLT-II again. The total number of words correctly recalled was computed (range = 0 to 16). Higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)6.2± 4.2
Active rTMS (Bilateral LPC)10.3± 3.6
Placebo rTMS (Inactive)6.2± 3.5
Depressive Symptoms, as Measured by the Geriatric Depression Scale (GDS), Assessed 1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

The 15-item Geriatric Depression Scale (GDS) was also used as an outcome measure. Five of the GDS items are oriented toward the absence of depressive symptoms (e.g., Do you feel full of energy?) and 10 are oriented toward current depressive symptoms (e.g., Do you often feel helpless?). The participant is asked to answer "yes" or "no" on the basis of how they have been feeling over the past week. The GDS total score ranges from 0 to 15. Lower values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)3.2± 2.3
Active rTMS (Bilateral LPC)1.9± 1.2
Placebo rTMS (Inactive)2.9± 2.3
Everyday Functional Outcomes, as Measured by the Everyday Cognition (ECog) Questionnaire (Participant Version) Completed 1 Week After Intervention Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention

The Everyday Cognition (ECog) questionnaire is comprised of 39 items about the ability to perform everyday tasks. Each item relates to memory, language, visual-spatial, or executive function. Each item is rated on a scale from 1 to 4 (1 = better or no change…4 = consistently much worse compared to 10 years ago). For the Participant version of the ECog, the participant is asked to "Please rate your ability to perform certain everyday tasks now, as compared to your ability to do these same tasks 10 years ago." Total score range: 39-156. Higher values represent a worse outcome. The outcome score

GroupValue95% CI
Active rTMS (Bilateral DLPFC)84.8± 21.0
Active rTMS (Bilateral LPC)66.1± 12.7
Placebo rTMS (Inactive)72.3± 16.1
Everyday Functional Outcomes, as Measured by the Everyday Cognition Questionnaire (Informant /Study Partner Version) Completed 1 Week After Intervention Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention

The Everyday Cognition (ECog) questionnaire is comprised of 39 items about the ability to perform everyday tasks. Each item relates to memory, language, visual-spatial, or executive function. Each item is rated on a scale from 1 to 4 (1 = better or no change…4 = consistently much worse compared to 10 years ago). For the Informant version of the ECog, the participant's study partner was asked to "Please rate the participant's ability to perform certain everyday tasks NOW, as compared to his/her ability to do these same tasks 10 years ago." Total score range: 39-156. Higher values represent a w

GroupValue95% CI
Active rTMS (Bilateral DLPFC)73.2± 30.9
Active rTMS (Bilateral LPC)61.1± 17.4
Placebo rTMS (Inactive)61.5± 29.2
Instrumental Activities of Daily Living (IADLs), as Measured by the Functional Assessment Questionnaire, Completed 1 Week After Intervention Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

Functional Assessment Questionnaire, completed by the study partner at end of treatment (1 week after intervention, adjusted for baseline). Each 10 item is rated on a scale from 0 to 3 (0 = Normal; 1 = Has difficulty, but does by self; 2 = Requires assistance; 3 = Dependent. Total score range: 0-30 (sum of 10 items). Interpretation: A total score of 9 (dependent in 3 or more activities) is the recommended cut-point for an indication of impaired function. Higher values represent a worse outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)3.29± 4.41
Active rTMS (Bilateral LPC)1.00± 1.32
Placebo rTMS (Inactive)1.33± 3.27
Global Cognitive Function, as Measured by the Montreal Cognitive Assessment (MoCA), Assessed 1 Week After Intervention and Adjusted for Baseline Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention

The Montreal Cognitive Assessment (MoCA) is a brief measure of global cognitive function. The total score has a range of 0 to 30; higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)23.0± 4.5
Active rTMS (Bilateral LPC)23.8± 2.8
Placebo rTMS (Inactive)23.6± 2.2
Visuospatial Memory, as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R), assessed1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

Brief Visuospatial Memory Test-Revised (BVMT-R) Trials 1-3 total recall raw score at end of treatment (1 week after intervention, adjusted for baseline); range: 0-36; higher values represent a better outcome

GroupValue95% CI
Active rTMS (Bilateral DLPFC)17.8± 8.5
Active rTMS (Bilateral LPC)18.5± 6.2
Placebo rTMS (Inactive)21.6± 6.5
Language Function, as Measured by Category Fluency (CF), Assessed 1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

Category Fluency is a measure of verbal fluency in which the participant is asked to generate different exemplars from a semantic category specified by the examiner. For example, if the examiner says, 'articles of clothing,' correct responses include exemplars such as, 'shirt,' 'tie,' or 'hat.' The participant is given one minute to say all the responses they can think of. The values reported reflect the total number of correct, unique responses produced. Higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)16.7± 3.8
Active rTMS (Bilateral LPC)19.8± 4.8
Placebo rTMS (Inactive)19.4± 6.0
Language Function, as Measured by 42-item Boston Naming Test (BNT), Assessed 1 Week After Intervention and Adjusted for Baseline Performance Secondary · 1 week after completing the 20-session intervention, which was typically 4 weeks after starting the intervention.

The Boston Naming Test (BNT) assesses the ability to verbally name pictured objects. The subject is shown a series of line drawings and asked to name the object. The test items become progressively more difficult. (The 42 items are presented in order of decreasing frequency of the target word). The total number of correct responses can range from 0 to 42. Higher values represent a better outcome.

GroupValue95% CI
Active rTMS (Bilateral DLPFC)36.3± 3.9
Active rTMS (Bilateral LPC)38.4± 3.8
Placebo rTMS (Inactive)35.9± 4.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from over a period of 6 to 12 months. The reporting timeframe for All-Cause Mortality and Serious Adverse Events is from enrollment and randomization until 6 months after completion of the 20-session device intervention, typically 7 months. The reporting timeframe for other adverse events is from enrollment and randomization until 1 week after completion of the 20-session device intervention, typically 1 month.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active rTMS (Bilateral DLPFC)
Serious: 1/14 (7%)
Deaths: 0/14
Active rTMS (Bilateral LPC)
Serious: 0/13 (0%)
Deaths: 0/13
Placebo rTMS (Inactive)
Serious: 2/13 (15%)
Deaths: 0/13

Serious adverse events (3 terms)

ReactionSystemActive rTMS (Bilateral DLP…Active rTMS (Bilateral LPC)Placebo rTMS (Inactive)
pancreatic cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)
hip fractureMusculoskeletal and connective tissue disorders
rotator cuff (surgerical repair)Musculoskeletal and connective tissue disorders
Other adverse events (10 terms — click to expand)

ReactionSystemActive rTMS (Bilateral DLP…Active rTMS (Bilateral LPC)Placebo rTMS (Inactive)
Site discomfortGeneral disorders
HeadacheNervous system disorders
Toothache/TMJ painGastrointestinal disorders
FatiguePsychiatric disorders
Muscle twitchingMusculoskeletal and connective tissue disorders
Site painGeneral disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
Low back painMusculoskeletal and connective tissue disorders
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders
Urinary incontinenceRenal and urinary disorders

Most-reported serious reactions: pancreatic cancer, hip fracture, rotator cuff (surgerical repair).

Data from ClinicalTrials.gov NCT03331796 adverse events section.

Sponsor's own description

The goal of this study is to test the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Mild Cognitive Impairment (MCI). Participants will be randomly assigned to one of three treatment groups: Group 1: Active Dorsolateral Prefrontal Cortex (DLPFC) rTMS; Group 2: Active Lateral Parietal Cortex (LPC) rTMS; and Group 3: Inactive rTMS (Placebo) control (evenly split between each coil location). Participation in the study takes approximately 7 ½ months-including a 2-to 4-week treatment phase (20 rTMS sessions) and a 6-month follow-up phase.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effects of repetitive transcranial magnetic stimulation in older adults with mild cognitive impairment: a protocol for a randomized, controlled three-arm trial.
    Taylor JL, Hambro BC, Strossman ND, Bhatt P, et al · · 2019 · cited 22× · PMID 31842821 · DOI 10.1186/s12883-019-1552-7
  2. Network-targeted transcranial magnetic stimulation (TMS) for mild cognitive impairment (MCI).
    Taylor JL, Bhatt P, Hernandez B, Iv M, et al · · 2025 · PMID 40513355 · DOI 10.1016/j.nicl.2025.103819

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Other recruiting trials for Mild Cognitive Impairment

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03331796.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing