Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TBI-ACUP

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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.

TBI-SHAM

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

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type DEVICE

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.

C-ACUP

This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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-SHAM

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

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Streitberger Needle

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes