Traumatic Brain InjuryTREAT-TBINCT02623218

Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

A study testing Acupuncture in people with Traumatic Brain Injury, run by AOMA Graduate School of Integrative Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Acupuncture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Nov 2015to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Prisoners or patients in custody
Current participation in an observational or intervention trial for TBI
Non-English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

Healing Response Acupuncture & Integrative Medicine
Dallas, Texas, 75214

Other trials in United States

About this study

Read the 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.

Conditions: Traumatic Brain Injury
Being tested: Acupuncture, Sham Acupuncture
Keywords: traumatic brain injury, acupuncture, transcranial doppler ultrasound
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureDevice
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 AcupunctureDevice
Also called Streitberger Needle
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.

Study groups in NCT02623218
Study group	Role	What they receive
TBI-ACUP	Experimental	This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Receives: Device: Acupuncture
TBI-SHAM	Sham comparator	This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Receives: Device: Sham Acupuncture
C-ACUP	Active comparator	This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Receives: Device: Acupuncture
C-SHAM	Sham comparator	This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Receives: Device: Sham Acupuncture
C-EX	Active comparator	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. Receives: Device: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)

Secondary outcomes (2)

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.
Measured: 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").
Measured: Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015May 2016

First posted7 Dec 2015 (estimated)
Study startNov 2015
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02623218
Sponsor's protocol ID: AOMA-5510
Acronym: TREAT-TBI
Status last verified: Jan 2020
First submitted: 3 Dec 2015
Last updated: 28 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 21417808
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.
PubMed 25226574
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.
PubMed 19848545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
ClinicalTrials.gov ID: NCT02623218
Acronym / sponsor ID: TREAT-TBI / AOMA-5510
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury, acupuncture, transcranial doppler ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: AOMA Graduate School of Integrative MedicineUniversity, hospital or other
Study start: Nov 2015
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 7 Dec 2015 (estimated)
Results: Posted 28 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
TBI-ACUP	Experimental	Device: AcupunctureThis group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.
TBI-SHAM	Sham comparator	Device: Sham AcupunctureThis group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI.
C-ACUP	Active comparator	Device: AcupunctureThis group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.
C-SHAM	Sham comparator	Device: Sham AcupunctureThis group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.
C-EX	Active comparator	Device: AcupunctureThis group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureAn 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.	Device	C-ACUP, C-EX, TBI-ACUP
Sham AcupunctureAlso: Streitberger NeedleSham 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.	Device	C-SHAM, TBI-SHAM

Primary outcome

Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).
Time frame: 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.

2 secondary outcomes

Changes in Hopkins Verbal Learning Test
Time frame: At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture
Rivermead Post-Concussion Survey
Time frame: Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only

Results and safety

Results posted to the registry on 28 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TBI-ACUP	5	5
TBI-SHAM	4	3
C-ACUP	4	4
C-SHAM	4	4
C-EX	4	4

Primary outcome: Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).

Time frame: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline). Mean (Standard Deviation). Unit: ml/sec

Measure	TBI-ACUP n = 5	TBI-SHAM n = 4	C-ACUP n = 4	C-SHAM n = 4	C-EX n = 4
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)	–	–	–

Population analysed: 1 participant in the TBI-SHAM group did not complete the study

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TBI-ACUP	0 of 5 (0%)	0 of 5 (0%)	0 of 5
TBI-SHAM	0 of 4 (0%)	0 of 4 (0%)	0 of 4
C-ACUP	0 of 4 (0%)	0 of 4 (0%)	0 of 4
C-SHAM	0 of 4 (0%)	0 of 4 (0%)	0 of 4
C-EX	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21417808Byeon 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.
Background: PubMed 25226574Im 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.
Background: PubMed 19848545An 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.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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TBI (Traumatic Brain Injury)
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Finnell, ND principal investigator

AOMA Graduate School of Integrative Medicine

Amy Moll, M.A.O.M. study director

AOMA Graduate School of Integrative Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Traumatic Brain Injury, run by AOMA Graduate School of Integrative Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). (time frame: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02623218, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.