Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial

Patients aged 45–80 years who (1) complain of or are reported by a relative or accompanying person as having cognitive decline; (2) have imaging evidence that supports cerebrovascular disease, and may or may not have a medical history of transient ischemic attack or other types of stroke; (3) have symptoms or signs caused by cerebrovascular disease (e.g., hemiplegia, hemiparesis, problems with understanding or forming speech, numbness or strange sensations); and (4) obtain the following results in the neuropsychological assessment under professional instruction from the neurologist: MoCA score < 26; clinical dementia rating scale score = 0.5; modified Rankin scale score ≤ 3; Hachinski ischemic score > 7 points, will be included in the study.

Patients who (1) have a Mini-mental State Examination score < 21; (2) have co-morbidity including AD, Parkinson’s disease, frontotemporal dementia, or Huntington’s disease, central nervous system inflammatory demyelinating disease, epilepsy, psychosis, liver or kidney dysfunction, hypothyroidism, alcoholic or drug abuse related encephalopathy, depression; and (3) have severe visual impairment, hearing impairment, severe aphasia or limb dysfunction which might affect pre-assessment, will be excluded from the study.

Patients who (1) have poor clinical compliance (2) quit the RCT voluntarily will be considered as having dropped out.

In this procedure, we used the formula for calculating the sample size of two sample rates for disordered classified data. Taking the results of previous research with a similar study design of acupuncture arm [15] (RR = 80%, OR = 15%) into consideration, a sample size of 100 patients (50 for each group) should be recruited. Allowing 20% attrition, the recruited sample size for this RCT will be of 120 patients (60 in each group).

Upon fulfillment of selection criteria, 120 eligible participants will be randomly allocated into the intervention and control groups in a 1:1 allocation ratio. Randomization will be performed according to a random list of numbers generated by the randomization center of Shanghai University of Traditional Chinese Medicine. An independent researcher, who contacts no participant and is not involved in the data collection or analysis, will take charge of the participant allocation based on the mentioned random list as well as on the allocation sequence concealment.

All participants will receive moderate financial subsidies to cover the travel expenses and should stick to the schedule for all treatments and assessments as much as possible. Those who are unable to visit the clinic at the time of reservation should inform the instructor by phone in advance to reschedule.

Patients will receive their intervention in a personal space separated by screens and no communication between them will be allowed. Treatment will be conducted in 8 consecutive weeks, at a frequency of three sessions per week in both intervention and control groups, and all manipulation should be consistent with the standards of the Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) [16]. In both groups, a 30 × 60-cm plastic plate with a notch will be applied on the patient’s chest as a visual barrier. In each session, after skin sterilization with alcohol wipes, the licensed and experienced acupuncturists will apply, with or without needle insertion, 0.25 × 25-mm needles to acupoints DU20, EX-HN3, DU24, DU26, and EX-HN1 and 0.30 × 40-mm needles for acupoints DU17, HT7, PC6, GB20, and SP6. A 2 × 2-cm piece of tape will be used to affix each needle to the skin of the chosen acupoints. The needles at DU20 and EX-HN3 will be connected to a G6805-2 Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, China) with electrode clamps. It will be implied to all patients that the sensation they are experiencing is the real acupuncture sensation. After a 30-min retention period, all needles and tape will be removed.

The intervention group will have a real tube-needle insertion applied with disposable stainless steel needles (Wuxi Jiajian Medical Material Co., Ltd., Wuxi, China). In the sitting position, DU17 will be punctured obliquely towards jaw to a depth of 0.5 cun into the skin. After that, in the supine position, DU20 (with the needle tip pointing towards the ground), EX-HN3, DU24, DU26, EX-HN1, and GB20 (with the needle tip pointing towards the feet) will be punctured obliquely to a depth of 0.5 cun, while HT7 and SP6 (with the needle tip pointing towards the limb extremities) will be punctured perpendicularly to the respective depth of 0.5 cun and 1–1.5 cun. Appropriate needle manipulation (including lifting, thrusting, and rotating) will be applied for 10 seconds on each point so that the needling sensation (De-qi sensation) can be accomplished at each point.

The control group will undergo treatment with a special sham acupuncture device with a blunt-tip needle. This type of needle can provoke a needling sensation quite similar to real acupuncture as soon as it touches the skin, without insertion. The acupuncturists should pretend to do the needle manipulation for 10 seconds on each point as well. Similarly, the needles on DU20 and EX-HN3 will be connected to a G6805-2 Multi-Purpose Health Device, with the device switched off, and will remain in place for the next 30 minutes.

The details of interventions are elaborated on Table 1.

The primary outcome measure includes changes of MoCA score. The MoCA test is a special tool to assess eight cognitive domains, including short-term memory recall, visuospatial abilities, language, attention, working memory, orientation to time and place, concentration as well as executive functions, among which the last two are the most notable aspects for VCIND. Executive functions are assessed by the alternating trail making task, verbal fluency task and the two-item verbal abstraction task; while concentration is evaluated by a sustained attention task, a serial subtraction task and digits forward and backward task. A final score ≥ 26 usually indicates normal cognitive ability, while a score below that level indicates cognitive impairment. This test will be administrated in approximately 10 minutes.

The ability of daily life will be evaluated by using the MBI. It involves 10 variables and a higher score indicates a greater likelihood of being able to live at home independently [18].

ERP provides a non-invasive way to evaluate brain function in patients with cognitive impairment by observing the typical electrophysiological response to a stimulus. In this RCT, it is the P300 component abnormalities (change of latent period and wave amplitude) that will be observed [19].