Clinical trial NCT02926378: Acupuncture for Stroke Recovery
Official title: Understanding the Cognitive Benefits of Acupuncture for Stroke Recovery Through fMRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Systematic Acupuncture
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Pre and Post Functional Imaging
timeFrame: 12 Months
measure: Pre and Post Cognitive Assessment
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Barbara Siminovich-blok
role: PRINCIPAL_INVESTIGATOR
References: