Clinical trial to investigate the effectiveness and safety of electroacupuncture and transcranial direct current stimulation combined with computerized cognitive rehabilitation for prevention of dementia
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0003644
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
1) Patients aged from 20 to 90years, 3months after stroke onset (verified by CT or MRI) and whose cognitive function is decreased
2) Korean version of the Montreal Cognitive Assessment (MoCA-K) score is below 22
3) Without blindness and able to communicate
4) No difficulty in reading and understanding Korean
5) Who voluntarily signed an informed consent form for participation in research
1) Cognitive function is impaired due to brain tumors, encephalitis or traumatic brain injury.
2) Who is decreased in cognitive function prior to the stroke.
3) Who has severe depression and psychiatric disorders that is difficult to adapt the treatment.
4) Who had changed their medications and other treatments that may affect cognitive impairment within the last 1 month
5) Contraindications to electrostimulation
(1) Metal in head (except in oral cavity)
- cochlear implants, electrode or stimulator, clips or coils for aneurysm, stents, bullet fragments, deep brain stimulator, vagus nerve stimulator, eyeball implant
(2) Who has pacemaker, defibrillator, neurostimulator, drug pump, intracardiac injection line
(3) Continuous convulsion symptoms
(4) Who received craniectomy, or ventriculo peritoneal shunt (VP shunt) surgery
(5) Who continuously complains of elevated intracranial pressure symptoms such as headache, vomiting or nausea and others
6) Contraindications to scalp acupuncture
(1) Wound or inflammation on the treatment region of scalp
(2) Who has a tendency not to be haemostatic due to abnormalities of blood clotting system, haemophilia or others
(3) Who had experienced serious unusual response after acupuncture treatment
7) Who cannot perform cognitive rehabilitation due to serious internal disease
8) Who cannot complete computer program due to musculoskeletal impairment, degenerative muscular disorders such as Parkinson disease, Huntington disease or others
9) Pregnant woman
10) Woman with pregnancy period
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method owenstein Occupational Therapy Cognitive Assessment (LOTCA)
- Secondary Outcome Measures
Name Time Method Cognitive therapy and brain training (RehaCom);Korean version of Modified Bathel Index (K-MBI);European Quality of Life Five Dimension (EQ-5D-3L)