Table 1 World Health Organization (WHO) trial registration data set
Data Category | Information |
|---|---|
Primary registry and trial identifying number | ClinicalTrials.gov NCT03331796 |
Date of registration in primary registry | 6 November, 2017 |
Source of monetary support | The National Institute on Aging |
Primary Sponsor | The National Institute on Aging |
Contact for public queries | Joshua Teso (Study Coordinator) 650–852-3457 |
Contact for scientific queries | Joy Taylor, PhD Stanford/VA Aging Clinical Research Center 3801 Miranda Avenue (151Y) VA Palo Alto Health Care System Palo Alto, CA, USA 94304–1207 |
Public Title | Noninvasive Brain Stimulation for Mild Cognitive Impairment |
Scientific title | Noninvasive Cortical Stimulation to Improve Memory in Mild Cognitive Impairment |
Countries of recruitment | USA |
Health condition or problem studied | Mild Cognitive Impairment (MCI), Other terms: Mild Neurocognitive Disorder, Memory Decline, Memory Loss, Memory Impairment |
Intervention (s) | Repetitive transcranial magnetic stimulation (rTMS), 10 Hz, 20 sessions Active comparators (Arms 1 and 2): rTMS Bilateral Dorsolateral Prefrontal Cortex (DLPFC); rTMS Bilateral Lateral Parietal Cortex (LPC) Placebo comparator (Arm 3): Inactive sham coil treatment |
Key Inclusion and Exclusion criteria | Inclusion: Age 55–90, amnestic MCI, stable medications, Geriatric Depression Scale score less than 6; Ability to obtain a motor threshold; Study partner available; Visual and auditory acuity adequate for neuropsychological testing; Good general health with no diseases expected to interfere with the study. Exclusion: Magnetic field safety concern such as a cardiac pacemaker, cochlear implant, metal fragments in the eyes, skin or body, or pregnancy; Any significant neurological disease other than suspected incipient Alzheimer’s disease; Unstable cardiac disease or recent myocardial infarction; Any significant systemic illness or unstable medical condition that could lead to difficulty with protocol adherence; History of epilepsy or repetitive seizure; History of a medical condition or current use/abuse of medications and substances that increase the risk of a seizure (e.g. recent traumatic brain injury, current use of stimulants), Known history of major depression or bipolar disorder within the past year; Current alcohol or substance abuse (not including caffeine or nicotine) within the past year. |
Study type | Interventional Device / Phase II Allocation: randomized Intervention model: parallel assignment (3 arms) Masking: double blind Primary Purpose: treatment |
Date of first enrollment | 16 May 2018 |
Target sample size | 99 |
Recruitment status | Recruiting |
Primary outcomes | Change in memory, as measured by the California Verbal Learning Test-II (CVLT-II) Trials 1–5 Total raw score [Time Frame: Baseline, 1 week after completing the 20-session intervention] |
Key Secondary outcomes | Behavioral outcomes include: Subscores of the CVLT-II, GDS, Everyday Cognition (ECog) Questionnaire, Montreal Cognitive Assessment (MoCA), tests of language, executive, and visuospatial function. Neuroimaging outcomes include: Change in functional connectivity metrics including comparison of DLPFC to LPC. Other biomarker outcomes: Change in brain-derived neurotropic factor (BDNF) plasma levels |