A randomized controlled trial to evaluate the effectiveness and safety of electro acupuncture and transcranial direct current stimulation with computerized cognitive rehabilitation in patients with vascular cognitive impairment
Bibliographic record
Abstract
BACKGROUND: Vascular cognitive impairment (VCI) refers to all cognitive disorders caused by cerebrovascular disorders. For the treatment, many types of pharmacologic and nonpharmacologic treatments are used but their underlying mechanisms and effects are unclear. Regarding nonpharmacologic treatment, electroacupuncture (EA), transcranial direct current stimulation (tDCS), and computerized cognitive rehabilitation treatment (CCRT) are effective. Here, we report the protocol for a randomized controlled trial of the effect and safety of combination therapy of EA or tDCS and CCRT in patients with VCI. METHODS: This study will be a prospective, outcome assessor-blinded, parallel-arm, randomized controlled clinical trial. Participants with cognitive impairment caused by stroke after 3 months of onset (n = 45) will be randomly assigned to a CCRT, combination therapy with EA and computerized cognitive rehabilitation treatment, or combination therapy with tDCS and computerized cognitive rehabilitation treatment group. All groups will receive treatment 3 times per week for 8 weeks, giving a total of 24 treatments. The CCRT group will perform a training task like shopping, calculating, and others and involving computerized cognitive assessment and brain training system (RehaCom) for 30 minutes. The combination therapy with EA and computerized cognitive rehabilitation treatment group will receive EA using 8 acupuncture points - baekhoe, sinjeong, both sides of pungji, 4 sites of sishencong - and will be applied using an EA stimulator and receive CCRT for 30 minutes at the same time. The combination therapy with tDCS and computerized cognitive rehabilitation treatment group will receive tDCS treatment and receive CCRT for 30 minutes at the same time. The primary outcome will be evaluated using the Lowenstein occupational therapy cognitive assessment, while other scales assessing walking ability, activities of daily living, and quality of life are considered secondary outcome measures. Outcomes will be evaluated before intervention, at the end of intervention 8 weeks after the first intervention, and 4 weeks after completion of the intervention program. DISCUSSION: This study aims to examine the effect and safety of combination therapy with EA or tDCS and CCRT in patients with VCI. This study can be useful in developing new treatment technologies using collaborative research with combined traditional Korean and conventional medicines. TRIAL REGISTRATION: This trial has been registered with cris.nih.go.kr (registration number, KCT 0003644 Registered 01 April 2019, http://cris.nih.go.kr).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.014 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".