Table 2.
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 |
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