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Acupuncture in Traumatic Brain Injury (AccuTBI)

Primary Purpose

Chronic Post-traumatic Headache, Mild Traumatic Brain Injury

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Chronic Post-traumatic Headache focused on measuring acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.
Unwilling to participate in all study related activities

Sites / Locations

HealthPartners Neuroscience Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low Dose

High Dose

Arm Description

Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.

Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Compliance with overall protocol

Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.

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.

Full Information

NCT ID

NCT04369911

First Posted

April 28, 2020

Last Updated

September 13, 2023

Sponsor

HealthPartners Institute

Collaborators

Minnesota Office of Higher Education

1. Study Identification

Unique Protocol Identification Number

NCT04369911

Brief Title

Acupuncture in Traumatic Brain Injury

Acronym

AccuTBI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 23, 2020 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HealthPartners Institute

Collaborators

Minnesota Office of Higher Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Post-traumatic Headache, Mild Traumatic Brain Injury

Keywords

acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Dose

Arm Type

Experimental

Arm Description

Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.

Arm Title

High Dose

Arm Type

Experimental

Arm Description

Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.

Intervention Type

Procedure

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in number of headache days

Description

The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.

Time Frame

baseline to 3 months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

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.

Time Frame

2 years

Title

Compliance with overall protocol

Description

Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.

Time Frame

3 months

Title

Compliance with treatment protocol

Description

Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality

Time Frame

3 months

Title

Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)

Description

The TBI-QOL-Headache contains questions about participant's headache pain. Range: 10-50. Raw score converted to T-score. Higher score indicates more headache pain.

Time Frame

3 months

Title

Change in Headache Duration

Description

The headache duration, measured in minutes for each headache day. Days will be totaled for the 4 week period measured. Higher number of headache minutes indicates worse headache control.

Time Frame

baseline to 3 months

Title

Change in Headache Pain Intensity

Description

The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches.

Time Frame

baseline to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amanda A Herrmann, PhD

Organizational Affiliation

HealthPartners Neuroscience Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

HealthPartners Neuroscience Center

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acupuncture in Traumatic Brain Injury

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