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Acupuncture in Traumatic Brain Injury | Clinical Trials | Clareo Health

COMPLETEDNA

Acupuncture in Traumatic Brain Injury

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

NCT04369911•HealthPartners Institute

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Key Dates

Start Date

November 23, 2020

Primary Completion Date

October 17, 2023

Completion Date

October 17, 2023

Last Updated

January 27, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Post-traumatic HeadacheMild Traumatic Brain Injury

Interventions

Acupuncture

PROCEDURE

Auditory Plasticity Training

NCT06628505

Mild Traumatic Brain Injury

View study

RECRUITINGNA

Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation

NCT06381674

Mild Traumatic Brain Injury, ConcussionRehabilitation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Acupuncture in Traumatic Brain Injury

Inclusion Criteria

Exclusion Criteria

Auditory Plasticity Training

Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

MindRhythm Detection of Concussion and Recovery Study

Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms

Facilitating Access to Specialty Treatment