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Table 1 World Health Organization (WHO) trial registration data set

From: The effects of repetitive transcranial magnetic stimulation in older adults with mild cognitive impairment: a protocol for a randomized, controlled three-arm trial

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
Joshua.Teso@va.gov
Contact for scientific queries Joy Taylor, PhD
joyt@stanford.edu
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