An interventional study of Acupuncture and Sham Acupuncture in Traumatic Brain Injury, sponsored by AOMA Graduate School of Integrative Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-28.
Sponsored by AOMA Graduate School of Integrative Medicine · Not applicable, Interventional, and Treatment
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.
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.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 22 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with AOMA Graduate School of Integrative Medicine as lead sponsor.
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Exclusion Criteria:
This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.
Device: Acupuncture
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
This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.
Device: Acupuncture
This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.
Device: Sham 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.
Device: 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.
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.
Also known as: Streitberger Needle
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)
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
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
| Milestone | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX |
|---|---|---|---|---|---|
| Started | 5 | 4 | 4 | 4 | 4 |
| Completed | 5 | 3 | 4 | 4 | 4 |
| Not completed | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 |
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.
| ml/sec | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX |
|---|---|---|---|---|---|
| Change in baseline to post-fight L MCA | 3.2 ± 4.8 | 6.7 ± 10.5 | — | — | — |
| Change in baseline to post-fight in R MCA | 4 ± 6.0 | 12.7 ± 8.4 | — | — | — |
| Change in baseline to post-fight in L ICA | -0.4 ± 6.8 | 3 ± 1.6 | — | — | — |
| Change in baseline to post-fight in R ICA | 2.4 ± 3.1 | 2.3 ± 2.6 | — | — | — |
| Change in baseline to post-fight in BA | 2.0 ± 4.9 | 4 ± 3.7 | — | — | — |
| Change in post-fight to post-acup/sham in L MCA | -5.6 ± 5.1 | -9.0 ± 2.2 | — | — | — |
| Change in post-fight to post-acup/sham in R MCA | 1.0 ± 6.0 | -3.0 ± 4.1 | — | — | — |
| Change in post-fight to post-acup/sham in L ICA | -0.6 ± 2.2 | -7.3 ± 1.2 | — | — | — |
| Change in post-fight to post-acup/sham in R ICA | -3.0 ± 5.7 | -4.7 ± 3.8 | — | — | — |
| Change in post-fight to post-acup/sham in BA | 2.0 ± 3.3 | -1.0 ± 5.0 | — | — | — |
| Change in baseline to post-acup/sham in L MCA | -2.0 ± 7.3 | -2.7 ± 9.0 | 7.3 ± 11.1 | -2.8 ± 4.4 | -5.8 ± 7.2 |
| Change in baseline to post-acup/sham in R MCA | 5.0 ± 2.7 | 9.7 ± 11.6 | 7.0 ± 8.7 | 5.0 ± 10.2 | -1.5 ± 2.3 |
| Change in baseline to post-acup/sham in L ICA | -1.4 ± 6.9 | -4.0 ± 2.2 | -2.3 ± 3.1 | 0.0 ± 1.9 | -2.8 ± 4.0 |
| Change in baseline to post-acup/sham in R ICA | -0.6 ± 5.0 | -2.3 ± 1.2 | -1.5 ± 7.3 | -3.0 ± 8.1 | -1.0 ± 1.6 |
| Change in baseline to post-acup/sham in BA | 4.0 ± 2.1 | 1.0 ± 4.3 | 6.5 ± 3.4 | 0.0 ± 7.9 | 2.3 ± 2.7 |
| Change in post-exercise to post acup/sham in L MCA | — | — | — | — | -3.5 ± 1.7 |
| Change in post-exercise to post acup/sham in R MCA | — | — | — | — | 1.0 ± 5.9 |
| Change in post-exercise to post acup/sham in L ICA | — | — | — | — | -2.3 ± 4.3 |
| Change in post-exercise to post acup/sham in R ICA | — | — | — | — | -1.5 ± 5.7 |
| Change in post-exercise to post acup/sham in BA | — | — | — | — | -0.5 ± 3.8 |
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.
| Units on a scale | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX |
|---|---|---|---|---|---|
| Baseline Total Recall Raw | 20.6 ± 2.33 | 25.7 ± 2.87 | 25.7 ± 1.70 | 28.5 ± 3.5 | 29 ± 3.54 |
| Post Acupuncture/sham Total Recall Raw | 27 ± 1.26 | 27.7 ± 1.25 | — | — | — |
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").
| Units on a scale | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX |
|---|---|---|---|---|---|
| Post-fight Rivermead | 8.4 ± 7.00 | 4 ± 2.94 | — | — | — |
| Post-acupuncture/sham Rivermea | 2.2 ± 3.92 | 1.7 ± 2.36 | — | — | — |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TBI-ACUP | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| TBI-SHAM | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| C-ACUP | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| C-SHAM | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| C-EX | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 4 | 4 | 4 | 21 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 5 | 4 | 4 | 4 | 4 | 21 |
| Region of Enrollment(participants) | TBI-ACUP | TBI-SHAM | C-ACUP | C-SHAM | C-EX | Total |
|---|---|---|---|---|---|---|
| United States | 5 | 4 | 4 | 4 | 4 | 21 |
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