N/A
N=21
Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02623218 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). — 3.2; 6.7; 4; 12.7 ml/sec
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Device); Sham Acupuncture (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AOMA Graduate School of Integrative Medicine
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). |
3.2; 6.7; 4; 12.7; -0.4; 3 | — |
| SECONDARY Changes in Hopkins Verbal Learning Test |
20.6; 25.7; 25.7; 28.5; 29; 27 | — |
| SECONDARY Rivermead Post-Concussion Survey |
8.4; 4; 2.2; 1.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02623218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.