Clinical trial NCT02623218: Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
Official title: Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
acupuncture
transcranial doppler ultrasound
Lead sponsor: AOMA Graduate School of Integrative Medicine
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of acupuncture on cerebral blood flow (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury, to determine if those changes correlate with changes in biomarkers of brain health, neuropsychological testing, and symptomatic presentation.

Detailed description: The primary aim of this study is to examine the effects of acupuncture on brain function and cognition during the acute 10-day window following mild traumatic brain injury.

Traumatic brain injuries (TBI) affect an estimated 1.7 to 2.3 million Americans every year. As the clinical importance of managing those with TBI grows, it is essential that therapies to help in the recovery and management of post-concussion symptoms are identified. Currently, the number one recommended treatment strategy is physical and cognitive rest, followed by gradual return to daily activities and exercise.

Cerebral blood flow declines following TBI, and can remain in a depressed state for ongoing lengths of time. The cellular vulnerability and symptomatic presentation following TBI is likely due to the metabolic imbalance between decreased cerebral blood flow and increased demand for glucose and adenosine triphosphate production. Animal and human studies have shown that acupuncture at locations both locally on the head and neck, as well as distally on the arms, hands, legs, and feet, can increase cerebral blood flow through the left (L) and right (R) middle cerebral artery (MCA), internal carotid artery (ICA), and basilar artery (BA).

Acupuncture has a long history of use in the treatment of acute and chronic pain, headaches, migraines, nausea, anxiety, and sleep disorders, however, studies specific to the utilization of acupuncture in managing symptoms following TBI are lacking.

The investigators hypothesize that that acupuncture treatments may improve cerebral blood flow resulting in overall improvements in brain function and cognition following TBI. Acupuncture may provide a safe treatment to improve outcomes following a TBI, and increase the rate of recovery.

Eligibility criteria: Inclusion Criteria:

* Age 18-50
* Documented TBI (for TBI-ACUP and TBI-SHAM arms)
* Visual acuity and hearing adequate for outcomes testing
* Fluency in English
* Ability to provide informed consent
* Acupuncture naïve

Exclusion Criteria:

* Significant polytrauma that may interfere with follow-up and outcome assessment
* Patients with major debilitating baseline mental health disorders that would interfere with the validity of outcome assessment due to TBI
* Patients on psychiatric hold
* Patients with major debilitating baseline neurological diseases impairing baseline awareness, cognition, or validity of outcome assessment due to TBI
* Significant history of pre-existing conditions that would interfere with the likelihood of follow-up and validity of outcome assessment due to TBI
* Pregnancy in female subjects
* Prisoners or patients in custody
* Current participation in an observational or intervention trial for TBI
* Non-English speakers

Primary outcomes:
measure: Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).
timeFrame: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)
Secondary outcomes:
measure: Changes in Hopkins Verbal Learning Test
timeFrame: At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture
measure: Rivermead Post-Concussion Survey
timeFrame: Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Healing Response Acupuncture & Integrative Medicine
state: Texas
Study officials:
affiliation: AOMA Graduate School of Integrative Medicine
name: John Finnell, ND
role: PRINCIPAL_INVESTIGATOR
affiliation: AOMA Graduate School of Integrative Medicine
name: Amy Moll, M.A.O.M.
role: STUDY_DIRECTOR
References:
citation: Byeon HS, Moon SK, Park SU, Jung WS, Park JM, Ko CN, Cho KH, Kim YS, Bae HS. Effects of GV20 acupuncture on cerebral blood flow velocity of middle cerebral artery and anterior cerebral artery territories, and CO2 reactivity during hypocapnia in normal subjects. J Altern Complement Med. 2011 Mar;17(3):219-24. doi: 10.1089/acm.2010.0232. Epub 2011 Feb 27.
citation: Im JW, Moon SK, Jung WS, Cho KH, Kim YS, Park TH, Ko CN, Park JM, Park SU, Cho SY. Effects of acupuncture at GB20 on CO2 reactivity in the basilar and middle cerebral arteries during hypocapnia in healthy participants. J Altern Complement Med. 2014 Oct;20(10):764-70. doi: 10.1089/acm.2013.0240. Epub 2014 Sep 16.
citation: An YS, Moon SK, Min IK, Kim DY. Changes in regional cerebral blood flow and glucose metabolism following electroacupuncture at LI 4 and LI 11 in normal volunteers. J Altern Complement Med. 2009 Oct;15(10):1075-81. doi: 10.1089/acm.2009.0257.