NCT02623218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 28, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

December 3, 2015

Results QC Date

June 26, 2017

Last Update Submit

January 20, 2020

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injuryacupuncturetranscranial doppler ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in Hopkins Verbal Learning Test

    At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture

  • Rivermead Post-Concussion Survey

    Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only

Study Arms (5)

TBI-ACUP

EXPERIMENTAL

This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI.

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.

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.

Device: Acupuncture

C-SHAM

SHAM COMPARATOR

This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group.

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.

Device: Acupuncture

Interventions

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.

C-ACUPC-EXTBI-ACUP
Sham AcupunctureDEVICE

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
C-SHAMTBI-SHAM

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healing Response Acupuncture & Integrative Medicine

Dallas, Texas, 75214, United States

Location

Related Publications (3)

  • 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.

    PMID: 21417808BACKGROUND

  • 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.

    PMID: 25226574BACKGROUND

  • 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.

    PMID: 19848545BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Dr. John Finnell
Organization
AOMA Graduate School of Integrative Medicine
jfinnell@aoma.edu
512-492-3057

Study Officials

  • John Finnell, ND

    AOMA Graduate School of Integrative Medicine

    PRINCIPAL INVESTIGATOR

  • Amy Moll, M.A.O.M.

    AOMA Graduate School of Integrative Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 7, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 28, 2020

Results First Posted

January 28, 2020

Record last verified: 2020-01

Locations

US(1)