Acupuncture in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.

Official Title
-----------------
Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury

Conditions
-----------------
Chronic Post-traumatic Headache, Mild Traumatic Brain Injury

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide and provision of signed and dated informed consent form Age 18-65 Diagnosis of mild traumatic brain injury (mTBI) (as defined by the International classification of headache disorders 3rd edition (ICHD-3); a. Either no loss of consciousness, or loss of consciousness of <30 minutes duration, b. Glascow Coma Scale (GCS) ≥ 13, and c. Symptoms and/or signs diagnostic of concussion) Diagnosis of mTBI ≥3 months and ≤12 months at the time of study enrollment Suffering from chronic post-traumatic headache (CPTH) of any etiology (e.g. tension or migraine), with chronic defined as developed within 7 days after injury and lasting ≥3 months from the time of injury Stable medication regimen for ≥1 months and agree to adhere to his or her current medication treatment regimen through study participation Exclusion Criteria: Non-English speaking History of acupuncture since diagnosis of mTBI History of pre-existing primary headache, defined as more than 12 days of tension-type headache annually and/or more than one migraine attacks per month in the last year History of any other serious neurological, psychiatric, chronic pain disorders, or seizures History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device Recent or active substance use disorder Women who are currently pregnant, lactating, or planning to become pregnant during the study Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators) Active participation or past participation ≤3 months in any other interventional study. Unwilling to participate in all study related activities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed. | Procedure: Acupuncture<br>* Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.<br>|
| Experimental: High Dose<br>Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed. | Procedure: Acupuncture<br>* Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of headache days | The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome. | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment. | 2 years | 
| Compliance with overall protocol | Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance. | 3 months | 
| Compliance with treatment protocol | Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture