Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, acupuncture, transcranial doppler ultrasound
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.
Interventions
DEVICEAcupuncture
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.
DEVICESham Acupuncture
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.
Sponsors
AOMA Graduate School of Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
One enrolled participant did not meet eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| TBI-ACUP This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.
Acupuncture: 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. | 5 |
| TBI-SHAM This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.
Sham Acupuncture: 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. | 4 |
| C-ACUP This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.
Acupuncture: 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. | 4 |
| C-SHAM This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.
Sham Acupuncture: 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. | 4 |
| C-EX 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.
Acupuncture: 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. | 4 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 21 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 4 participants | 4 participants | 4 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)
Population: 1 participant in the TBI-SHAM group did not complete the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in BA | 2.0 ml/sec | Standard Deviation 4.9 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in R ICA | -3.0 ml/sec | Standard Deviation 5.7 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in R MCA | 4 ml/sec | Standard Deviation 6 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in BA | 2.0 ml/sec | Standard Deviation 3.3 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in L MCA | -5.6 ml/sec | Standard Deviation 5.1 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L MCA | -2.0 ml/sec | Standard Deviation 7.3 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in R ICA | 2.4 ml/sec | Standard Deviation 3.1 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in BA | 4.0 ml/sec | Standard Deviation 2.1 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R ICA | -0.6 ml/sec | Standard Deviation 5 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight L MCA | 3.2 ml/sec | Standard Deviation 4.8 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R MCA | 5.0 ml/sec | Standard Deviation 2.7 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in R MCA | 1.0 ml/sec | Standard Deviation 6 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L ICA | -1.4 ml/sec | Standard Deviation 6.9 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in L ICA | -0.4 ml/sec | Standard Deviation 6.8 |
| TBI-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in L ICA | -0.6 ml/sec | Standard Deviation 2.2 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L ICA | -4.0 ml/sec | Standard Deviation 2.2 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight L MCA | 6.7 ml/sec | Standard Deviation 10.5 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in R MCA | 12.7 ml/sec | Standard Deviation 8.4 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in L ICA | 3 ml/sec | Standard Deviation 1.6 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in R ICA | 2.3 ml/sec | Standard Deviation 2.6 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-fight in BA | 4 ml/sec | Standard Deviation 3.7 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in L MCA | -9.0 ml/sec | Standard Deviation 2.2 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in R MCA | -3.0 ml/sec | Standard Deviation 4.1 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in L ICA | -7.3 ml/sec | Standard Deviation 1.2 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in R ICA | -4.7 ml/sec | Standard Deviation 3.8 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-fight to post-acup/sham in BA | -1.0 ml/sec | Standard Deviation 5 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L MCA | -2.7 ml/sec | Standard Deviation 9 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R MCA | 9.7 ml/sec | Standard Deviation 11.6 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R ICA | -2.3 ml/sec | Standard Deviation 1.2 |
| TBI-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in BA | 1.0 ml/sec | Standard Deviation 4.3 |
| C-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R MCA | 7.0 ml/sec | Standard Deviation 8.7 |
| C-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L ICA | -2.3 ml/sec | Standard Deviation 3.1 |
| C-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R ICA | -1.5 ml/sec | Standard Deviation 7.3 |
| C-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L MCA | 7.3 ml/sec | Standard Deviation 11.1 |
| C-ACUP | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in BA | 6.5 ml/sec | Standard Deviation 3.4 |
| C-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R MCA | 5.0 ml/sec | Standard Deviation 10.2 |
| C-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in BA | 0.0 ml/sec | Standard Deviation 7.9 |
| C-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R ICA | -3.0 ml/sec | Standard Deviation 8.1 |
| C-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L ICA | 0.0 ml/sec | Standard Deviation 1.9 |
| C-SHAM | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L MCA | -2.8 ml/sec | Standard Deviation 4.4 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R MCA | -1.5 ml/sec | Standard Deviation 2.3 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in BA | 2.3 ml/sec | Standard Deviation 2.7 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-exercise to post acup/sham in L MCA | -3.5 ml/sec | Standard Deviation 1.7 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L MCA | -5.8 ml/sec | Standard Deviation 7.2 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-exercise to post acup/sham in R MCA | 1.0 ml/sec | Standard Deviation 5.9 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in L ICA | -2.8 ml/sec | Standard Deviation 4 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-exercise to post acup/sham in R ICA | -1.5 ml/sec | Standard Deviation 5.7 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-exercise to post acup/sham in L ICA | -2.3 ml/sec | Standard Deviation 4.3 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in baseline to post-acup/sham in R ICA | -1.0 ml/sec | Standard Deviation 1.6 |
| C-EX | Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). | Change in post-exercise to post acup/sham in BA | -0.5 ml/sec | Standard Deviation 3.8 |
Secondary
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.
Time frame: At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture
Population: 1 participant in the TBI-SHAM group did not complete the study. Data were not collected for the Post-Exercise Total Recall Raw assessment for all groups, and not for Post Acupuncture/sham Total Recall Raw assessment in the CACUP, C-SHAM and C-EX Arms/Groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TBI-ACUP | Changes in Hopkins Verbal Learning Test | Post Acupuncture/sham Total Recall Raw | 27 Units on a scale | Standard Deviation 1.26 |
| TBI-ACUP | Changes in Hopkins Verbal Learning Test | Baseline Total Recall Raw | 20.6 Units on a scale | Standard Deviation 2.33 |
| TBI-SHAM | Changes in Hopkins Verbal Learning Test | Baseline Total Recall Raw | 25.7 Units on a scale | Standard Deviation 2.87 |
| TBI-SHAM | Changes in Hopkins Verbal Learning Test | Post Acupuncture/sham Total Recall Raw | 27.7 Units on a scale | Standard Deviation 1.25 |
| C-ACUP | Changes in Hopkins Verbal Learning Test | Baseline Total Recall Raw | 25.7 Units on a scale | Standard Deviation 1.7 |
| C-SHAM | Changes in Hopkins Verbal Learning Test | Baseline Total Recall Raw | 28.5 Units on a scale | Standard Deviation 3.5 |
| C-EX | Changes in Hopkins Verbal Learning Test | Baseline Total Recall Raw | 29 Units on a scale | Standard Deviation 3.54 |
Secondary
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).
Time frame: Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only
Population: The groups with zero did not take this post-concussion survey because those participants were healthy controls who did not have a concussion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TBI-ACUP | Rivermead Post-Concussion Survey | Post-fight Rivermead | 8.4 Units on a scale | Standard Deviation 7 |
| TBI-ACUP | Rivermead Post-Concussion Survey | Post-acupuncture/sham Rivermea | 2.2 Units on a scale | Standard Deviation 3.92 |
| TBI-SHAM | Rivermead Post-Concussion Survey | Post-fight Rivermead | 4 Units on a scale | Standard Deviation 2.94 |
| TBI-SHAM | Rivermead Post-Concussion Survey | Post-acupuncture/sham Rivermea | 1.7 Units on a scale | Standard Deviation 2.36 |