Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Interventions
- Device: AcupunctureDevice: Sham Acupuncture
- Registration Number
- NCT02623218
- Lead Sponsor
- AOMA Graduate School of Integrative Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C-ACUP Acupuncture This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. C-EX Acupuncture This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. TBI-SHAM Sham Acupuncture This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. TBI-ACUP Acupuncture This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. C-SHAM Sham Acupuncture This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.
- Primary Outcome Measures
Name Time Method Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline) Cerebral blood flow velocity was assessed at baseline, post-fight, and post-acupuncture in the TBI-ACUP arm.
Cerebral blood flow velocity was assessed at baseline, post fight, and post-sham acupuncture in the TBI-SHAM arm.
Cerebral blood flow velocity was assessed at baseline, post exercise, and post-acupuncture in the C-EX arm.
Cerebral blood flow velocity was assessed at baseline, and post-acupuncture in the C-ACUP arm.
Cerebral blood flow velocity was assessed at baseline, and post-sham acupuncture in the C-SHAM arm.
- Secondary Outcome Measures
Name Time Method Changes in Hopkins Verbal Learning Test At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture The Hopkins Verbal Learning Test consists of a 12-item word list, composed of four words from each of three semantic categories which the patient must learn over three trials. For each trial, the subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The score for total recall is the sum of all the correctly-recalled words from each trial, ranging from 0 to 36, with higher scores indicating better recall and retention.
Rivermead Post-Concussion Survey Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity").
Trial Locations
- Locations (1)
Healing Response Acupuncture & Integrative Medicine
🇺🇸Dallas, Texas, United States