Acupuncture Treatment on Cerebral Blood Flow

NCT04346511 | Withdrawn Phase 2 DMC

• 1 other identifier: 11943
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (3)

• Cerebrovascular Conductance Index

  Middle Cerebral Artery Blood Velocity relative to Mean Arterial Pressure (MCABV/MAP)

  5 min of moderate exercise

• Middle cerebral artery blood velocity

  Velocity of blood through the middle cerebral arteries

  5 min of moderate exercise

• Mean Arterial Pressure

  Integral of blood pressure waveform

  5 min of moderate exercise

Secondary Outcomes (9)

• Heart Rate Variability

  before and after acupuncture

• End-tidal CO2

  5 min of moderate exercise

• Oxygen Uptake

  5 min of moderate exercise

• peripheral capillary oxygen saturation

  5 min of moderate exercise

• Tissue saturation index

  5 min of moderate exercise

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Sham Acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture OTHER

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.

Also known as: Sham Acupuncture

Acupuncture; Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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
• If they are on anti-hypertensive medication, the dose, type, and frequency of use will be recorded.
• 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:
• Normotensive
• Free of cardiovascular comorbidities.

You may not qualify if:

• Diabetes
• Coronary artery disease
• Stroke
• Heart attack
• Sleep apnea
• Tobacco use
• Asthma
• Pregnancy
• Currently receiving antihypertensive acupuncture treatment
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Department of Health and Exercise Science

Norman, Oklahoma, 73019, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jeremy M Kellawan, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: May 9, 2020
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)