Systematic AcupunctureNCT02926378
Acupuncture for Stroke Recovery
A study testing Acupuncture Treatments in people with Systematic Acupuncture, run by NYU Langone Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systematic Acupuncture
- What is being tested?
- Acupuncture Treatments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2016to 28 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have experienced a left Cerebrovascular Accident (CVA) at least one year prior to study participation and the injury timeframe is 1-10 years post stroke
- Be able to participate in the cognitive testing that has been validated with English-speaking samples
- Be right hand dominant
- Have an educational level between 14-18 years
- Evidence history of cognitive decline post-stroke without significant impairment
- Have adequate vision, hearing, communication, and motor skills
Who cannot join
- Evidence cognitive impairment that would negatively impact capacity to understand and participate in this study
- Be participating in active therapeutic treatments that may independently improve cognitive function
- Have had a change in medication over two weeks before the start of study procedures or through the study protocol
- Have contraindications for acupuncture or MRI.
- Contraindications to fMRI include:
- having a pacemaker, defibrillator or wires other than sternal wires.
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- Metallic foreign body in the eye - these might move or heat during scanning resulting in serious eye injury.
- Deep brain stimulator
- Swan-Ganz catheter
- Bullets or gunshot pellets - near great vessels or vital organs, such as the lungs, heart or brain,
- Cerebral aneurysm clips - if magnetic, can move. Also not scanned if type unknown.
- Cochlear implant - malfunction.
- Magnetic dental implants - loss of magnetic hold to keep the implant in place.
- Certain Drug infusion devices
- Main contraindications for acupcunture in this study include: Pregnancy, IV anticoagulant therapy, uncontrolled coagulation blood disorders like haemophilia, malignant tumors, and fear of needles.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Understanding the Cognitive Benefits of Acupuncture for Stroke Recovery Through fMRI
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.
Read the detailed description
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.
- Conditions
- Systematic Acupuncture
- Being tested
- Acupuncture Treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture TreatmentsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Intervention | Experimental | 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. Receives: Procedure: Acupuncture Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start18 Nov 2016
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systematic AcupunctureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Siminovich-blok, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926378
- Sponsor's protocol ID
- 15-00439
- Status last verified
- Feb 2020
- First submitted
- 4 Oct 2016
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Cognitive Benefits of Acupuncture for Stroke Recovery Through fMRI
- ClinicalTrials.gov ID
- NCT02926378
- Acronym / sponsor ID
- 15-00439
- Conditions
- Systematic Acupuncture
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Intervention | Experimental | Procedure: Acupuncture TreatmentsEvery 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must have experienced a left Cerebrovascular Accident (CVA) at least one year prior to study participation and the injury timeframe is 1-10 years post stroke
- Be able to participate in the cognitive testing that has been validated with English-speaking samples
- Be right hand dominant
- Have an educational level between 14-18 years
- Evidence history of cognitive decline post-stroke without significant impairment
Key exclusion criteria (15 listed)
- Evidence cognitive impairment that would negatively impact capacity to understand and participate in this study
- Be participating in active therapeutic treatments that may independently improve cognitive function
- Have had a change in medication over two weeks before the start of study procedures or through the study protocol
- Have contraindications for acupuncture or MRI.
- having a pacemaker, defibrillator or wires other than sternal wires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture TreatmentsEvery 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 or surgery | Acupuncture Intervention |
Primary outcome
Pre and Post Functional Imaging
Time frame: 12 Months
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.
Pre and Post Cognitive Assessment
Time frame: 12 Months
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).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Siminovich-blok principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Treatments in people with Systematic Acupuncture, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre and Post Functional Imaging (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.