Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury (TREAT-TBI)

AOMA Graduate School of Integrative Medicine

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: Acupuncture; Device: Sham Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02623218

AOMA-5510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 5 patient groups

TBI-ACUP

Experimental group

Description:

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

Treatment:

Device: Acupuncture

TBI-SHAM

Sham Comparator group

Description:

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

Treatment:

Device: Sham Acupuncture

C-ACUP

Active Comparator group

Description:

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

Treatment:

Device: Acupuncture

C-SHAM

Sham Comparator group

Description:

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

Treatment:

Device: Sham Acupuncture

C-EX

Active Comparator group

Description:

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.

Treatment:

Device: Acupuncture