Acupuncture Treatment on Cerebral Blood Flow
Acupuncture Treatment on Cerebral Blood Flow
Cerebrovascular diseases (CVD) and neurodegenerative diseases (NDD) are both leading causes
 of death in the United States. Epidemiological data have shown that increased prevalence of
 hypertension is related to these outcomes. However, despite the strong association of poor
 brain health outcomes in patients with hypertension (HTN), the understanding of cerebral
 blood flow (CBF) regulation and treatment options for HTN remain limited. Acupuncture
 treatment (AT), which is considered a promising complementary and integrative modality, has
 been known to reduce blood pressure and improve endothelial function in HTN. However, very
 few studies have investigated AT's effect on cerebrovascular function and the possible
 neuroprotective properties directly via regulating HTN. Exercise is used as a stimulus that
 increases the brain's metabolism and requires cerebrovascular responses (vasodilation) to
 meet the new metabolism.

 Therefore, the specific aim of this study is to test the hypothesis that an antihypertensive
 acupuncture treatment can acutely improve cerebrovascular responses in hypertensive humans
 during moderate exercise.
After IRB approval, experiments will take place in the Human Circulation Research Laboratory
 in the Department of Health and Exercise on the OU Norman campus. All subjects will complete
 a total of 3 visits. The first is a screening visit to provide informed consent and to ensure
 the potential participant meets all inclusion criteria and no exclusion criteria. Once
 enrolled, participants will complete two experimental trials (Placebo (PL, Sham Acupuncture)
 or Real Acupuncture (RA), randomized) in a single-blinded crossover design. PL or RA
 treatment will precede testing by ~25min before to maximize acute responses. Test begins with
 5 min of quiet rest where baseline measurements are taken, followed by 5 min of exercise.
 After exercise, subjects will be given 5 min of quiet rest.

 Visit 1 (Screening day): ~1.5 hours. The screening visit will include informed consent,
 health history, physical activity questionnaires and blood sample. If qualified, the subject
 will be enrolled in the study and they will complete a maximal oxygen uptake (VO2max) cycle
 ergometer test to determine fitness.

 Visit 2 & 3 (Study day): ~1.5 hours. Instrumentation: Subjects will be equipped with ECG for
 heart rate (HR), photoplethysmography for blood pressure, pulse oximeter, mouthpiece for
 end-tidal CO2 (PETCO2) and oxygen uptake (VO2), near-infrared spectroscopy (NIRS) for active
 muscle oxygenation and Transcranial Doppler (TCD) for CBF. Real Acupuncture (RA): Subjects
 will receive ~20 minutes of RA treatment prior to exercise. Placebo (PL): Specially designed
 Sham Acupuncture needles will be used in the same acupoints, for the same duration as RA.

 All subjects will complete a total of 3 visits separated by a minimum of 48 hours. Each study
 visit will take ~1.5 hours. The investigators anticipate ~ 6 hours or less of total
 involvement of the participants' time.

 This study is a single-blind crossover design. Participants will be blinded in two trials.
 Practitioners and operators will not be allowed to communicate with the participants
 concerning the type of acupuncture devices. Outcome assessors and statisticians may not be
 blinded to treatment allocation.

 The key dependent variable of interest is change (delta) in cerebrovascular conductance index
 (CVCi = CBF/blood pressure) from rest to exercise (delta CVCi = CVCiExercise - CVCiRest).
 Delta CVCi is the most common assessment of vasodilation in humans as it normalizes
 differences in blood flow to differences in blood pressure. CVCi calculates how much blood
 flow is observed for a given pressure. A change in CVCi (delta CVCi) has a predictable
 relationship where + delta CVCi indicates vasodilation (more flow for a given pressure) and -
 delta CVCi indicates vasoconstriction (less flow for a given pressure). Data will be analyzed
 using a general linear model approach (similar to ANOVA). Based on pilot data, a total sample
 size of 40 (20 CON and 20 HTN) will provide a power of 0.9. A minimum of 60 participants will
 be to recruited to ensure statistical power is achieved.
Inclusion Criteria:

 Subjects will include healthy controls (CON) and Hypertension (HTN) patients between 18-65
 years of age. Female participants if premenopausal will be studied in the early follicular
 phase of their cycle to minimize vascular effects of circulating hormones.

 HTN:

 1) Stage 1 hypertensive, Systolic BP (SBP) ≥ 130 mmHg and/or Diastolic BP (DBP) > 80 mmHg,
 and/or diagnosis of HTN, with BMI and physical activity levels ≈ CON

 1. If they are on anti-hypertensive medication, the dose, type, and frequency of use will
 be recorded.

 2. HTN with an SBP > 139 mmHg must have a medical doctor's permission to participate

 CON: will be age, BMI, menstrual status for females, and physical activity matched to HTN.
 They must be:

 1. Normotensive

 2. Free of cardiovascular comorbidities.

 Exclusion Criteria:

 1. Diabetes

 2. Coronary artery disease

 3. Stroke

 4. Heart attack

 5. Sleep apnea

 6. Tobacco use

 7. Asthma

 8. Pregnancy

 9. Currently receiving antihypertensive acupuncture treatment

 10. conditions where acupuncture might not be safe, such as metal allergy or
 needle-phobia. If a subject experiences severe acupuncture-associated response, it
 will be subject to early termination of the study.