Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBI-ACUP<br>This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. | Device: Acupuncture<br>* An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.<br>|
| Sham Comparator: TBI-SHAM<br>This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. | Device: Sham Acupuncture<br>* Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.<br>* Other names: Streitberger Needle;|
| Active Comparator: C-ACUP<br>This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. | Device: Acupuncture<br>* An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.<br>|
| Sham Comparator: C-SHAM<br>This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. | Device: Sham Acupuncture<br>* Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.<br>* Other names: Streitberger Needle;|
| Active Comparator: C-EX<br>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. | Device: Acupuncture<br>* An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | 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. | At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Hopkins Verbal Learning Test | 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. | At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture | 
| Rivermead Post-Concussion Survey | 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). | Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, acupuncture, transcranial doppler ultrasound