Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture Treatment on Cerebral Blood Flow (Amp-HTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346511
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
High Blood Pressure Other: Acupuncture Phase 2

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Real Acupuncture(RA): In a supine position with a cardboard blocking view of their legs, patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed.

Placebo (PL): Specially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site.

Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Effects of Anti-Hypertensive Acupuncture Treatment on Cerebral Blood Flow Responses to Exercise in Hypertensive Humans
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
In a supine position with a cardboard blocking view of their legs, patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed.
Other: Acupuncture
Patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal.
Other Name: Sham Acupuncture

Sham Comparator: Sham Acupuncture
Specially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site.
Other: Acupuncture
Patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal.
Other Name: Sham Acupuncture




Primary Outcome Measures :
  1. Cerebrovascular Conductance Index [ Time Frame: 5 min of moderate exercise ]
    Middle Cerebral Artery Blood Velocity relative to Mean Arterial Pressure (MCABV/MAP)

  2. Middle cerebral artery blood velocity [ Time Frame: 5 min of moderate exercise ]
    Velocity of blood through the middle cerebral arteries

  3. Mean Arterial Pressure [ Time Frame: 5 min of moderate exercise ]
    Integral of blood pressure waveform


Secondary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: before and after acupuncture ]
    measure of the variation in time between each heartbeat

  2. End-tidal CO2 [ Time Frame: 5 min of moderate exercise ]
    Partial pressure carbon dioxide (CO2) at the end of an exhaled breath

  3. Oxygen Uptake [ Time Frame: 5 min of moderate exercise ]
    Volume of oxygen consumed by the body per minute

  4. peripheral capillary oxygen saturation [ Time Frame: 5 min of moderate exercise ]
    estimate of the amount of oxygen in the blood

  5. Tissue saturation index [ Time Frame: 5 min of moderate exercise ]
    estimate of the amount of oxygen in muscle

  6. blood glucose levels [ Time Frame: prior to enrollment ]
    venous blood content

  7. blood triglyceride levels [ Time Frame: prior to enrollment ]
    venous blood content

  8. blood high density lipoprotein levels [ Time Frame: prior to enrollment ]
    venous blood content

  9. blood low density lipoprotein levels [ Time Frame: prior to enrolment ]
    venous blood content



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346511


Contacts
Layout table for location contacts
Contact: Jeremy M Kellawan, PhD 405-325-9028 kellawan@ou.edu
Contact: Jongjoo Sun, PhD, KMD (405) 306-7517 jongjoosun@ou.edu

Locations
Layout table for location information
United States, Oklahoma
Department of Health and Exercise Science
Norman, Oklahoma, United States, 73019
Contact: Michael Bemben, PhD    405-325-5211    mgbemben@ou.edu   
Contact: Jeremy M Kellawan, PhD    (405) 325-9028    kellawan@ou.edu   
Principal Investigator: Jeremy M Kellawan, PhD         
Sub-Investigator: Jongjoo Sun, PhD, KMD         
Sponsors and Collaborators
University of Oklahoma
Investigators
Layout table for investigator information
Principal Investigator: Jeremy M Kellawan, PhD University of Oklahoma
Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04346511    
Other Study ID Numbers: 11943
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases