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Behavioural Intervention

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

N/A

Waitlist Available

Led By John Finnell, ND

Research Sponsored by AOMA Graduate School of Integrative Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-fight, post-acupuncture/sham - tbi-acup and tbi-sham groups only

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.

Eligible Conditions

Traumatic Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arterial Lines

Secondary study objectives

Changes in Hopkins Verbal Learning Test

Rivermead Post-Concussion Survey

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: TBI-ACUPExperimental Treatment1 Intervention

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

Group II: C-ACUPActive Control1 Intervention

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

Group III: C-EXActive Control1 Intervention

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 IV: C-SHAMPlacebo Group1 Intervention

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

Group V: TBI-SHAMPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240