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Table 2 The items from the World Health Organization Trial Registration Data Set

From: Neurocircuitry of acupuncture effect on cognitive improvement in patients with mild cognitive impairment using magnetic resonance imaging: a study protocol for a randomized controlled trial

Data category

Information

Primary registry and trial identifying number

CRIS KCT0002896

Date of registration in primary registry

25 May 2018

Sponsor

KIOM

Contact for public/scientific queries

JHL, KMD, Ph.D (omdjun@kiom.re.kr)

Public title

None

Scientific title

Neurocircuitry of Acupuncture Effect on Cognitive Improvement in Patients with Mild Cognitive Impairment Using Magnetic Resonance Imaging: A Study Protocol for a Randomized Controlled Trial

Countries of recruitment

Republic of Korea

Health condition(s) or problem(s) studied

MCI

Intervention(s)

Active comparator: acupuncture

Sham comparator: non-penetrating sham acupuncture

Key inclusion and exclusion criteria

Ages eligible for study: 50–70 years; sexes eligible for study: both; accepts healthy volunteers: no

Inclusion criteria: diagnosis of MCI, MoCA-K < 23, CDR score of 0.5, GDS grade 2–3

Exclusion criteria: diagnosis of dementia, neurological disorders, mental disorders

Study type

Interventional

Allocation: randomized; intervention model: parallel assignment; blinding: subject-assessor blinding

Primary purpose: treatment

Date of first enrolment

18 July 2018

Target sample size

50

Recruitment status

Recruiting

Primary outcome(s)

DST

Key secondary outcomes

DSST, MoCA-K

  1. CRIS Clinical Research Information Service, DSST Digit Symbol Substitution Test, DST Digit Span Test, MCI mild cognitive impairment, MoCA-K Korean version of Montreal Cognitive Assessment, KIOM Korean Institute of Oriental Medicine