An interventional study of Acupuncture Treatments in Systematic Acupuncture, sponsored by NYU Langone Health. Terminated at 1 site in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
Based on the evidence, a pre-post test pilot study design will be implemented to clarify the benefits of an acupuncture intervention before and after treatment. The initial assessment will contain a brief demographic interview and a review of medical records, and both pre and post-intervention evaluations will comprise an imaging protocol that includes RS-fMRI, pCASL, diffusion kurtosis imaging (DKI), and a brief cognitive assessment, as described in greater detail below. Several quantitative measures within DMN regions will be generated and compared between pre- and post-acupuncture therapy. These include 1) RS-fMRI measures such as connectivity strength and fractional amplitude of low frequency fluctuations (fALFF); 2) regional CBF measured with pCASL; 3) water diffusion measures for microstructural changes with DKI.
A pilot sample of 5 individuals with left CVA's will participate in a 6 session acupuncture intervention. Pre and post fMRI and cognitive data will be compared.
The objectives of this study are 1) to determine the effects of acupuncture in improving cognitive performance in a pilot sample of 5 individuals who have experienced a left CVA and 2) to clarify the mechanism of improvement via functional brain imaging.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
Contraindications to fMRI include:
Every participant will receive six acupuncture treatments across a three to four-week period. The treatments will last a total of about one hour, including a 10 minute initial assessment, needling, and 45 min of lying down with the needles. Two treatments a week will be performed by Dr. Siminovich-Blok, the PI of this study and a NYS licensed acupuncturist at NYU Langone Medical Center (NYULMC) Ambulatory Care Center. Each acupuncture treatment will consist of 1) a combination of a fixed set of points suggested by the literature, and 2) an individualized set of points based on the evaluation by the licensed acupuncturist. The first set of points will consist of 4 acupoints used consistently in the treatment of stroke through the literature.
Procedure: Acupuncture Treatments
Every participant will receive six acupuncture treatments across a three to four-week period. The treatments will last a total of about one hour, including a 10 minute initial assessment, needling, and 45 min of lying down with the needles. Two treatments a week will be performed by Dr. Siminovich-Blok, the PI of this study and a NYS licensed acupuncturist at NYU Langone Medical Center (NYULMC) Ambulatory Care Center. Each acupuncture treatment will consist of 1) a combination of a fixed set of points suggested by the literature, and 2) an individualized set of points based on the evaluation by the licensed acupuncturist. The first set of points will consist of 4 acupoints used consistently in the treatment of stroke through the literature.
Pre and Post Functional Imaging
It is difficult to conduct resting state analysis with this small N due to its large inherent variability. Visual analysis, as described below, will be utilized to compare changes in fMRI scans before and after the acupuncture intervention. The fMRI is a self-control comparison in this study.
Time frame: 12 Months
Pre and Post Cognitive Assessment
Based on the small number of patients for this study, we will begin by evaluating effect sizes on the differences between cognitive performance before and after the acupuncture intervention. Contingent on the findings, we may then implement a paired two sample t-test or Wilcoxon signed rank test. The paired test allows each participant to serve as his/her own control to maximize power and reduce potential confounds (i.e., potential effects of fatigue during assessment).
Time frame: 12 Months
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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