Acupuncture in Traumatic Brain Injury (AccuTBI)

• ClinicalTrials.gov Identifier: NCT04369911
• Recruitment Status: Enrolling by invitation
• First Posted: April 30, 2020
• Last Update Posted: September 28, 2022
• Sponsor: HealthPartners Institute
• Collaborator: Minnesota Office of Higher Education
• Information provided by (Responsible Party): HealthPartners Institute

Tracking Information

• First Submitted Date: April 28, 2020
• First Posted Date: April 30, 2020
• Last Update Posted Date: September 28, 2022
• Actual Study Start Date: November 23, 2020
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2020)

Change in number of headache days [ Time Frame: baseline to 3 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 28, 2020)

• Adverse Events [ Time Frame: 2 years ]
  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 [ Time Frame: 3 months ]
  Completion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
• Compliance with treatment protocol [ Time Frame: 3 months ]
  Completion of treatment duration. Proportion of participants completed the full 30 minutes treatment session. Range: 0-1. A higher proportion indicates more compliance.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 27, 2020)

• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ]
  The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality
• Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) [ Time Frame: 3 months ]
  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.
• Change in Headache Duration [ Time Frame: baseline to 3 months ]
  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.
• Change in Headache Pain Intensity [ Time Frame: baseline to 3 months ]
  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.

Original Other Pre-specified Outcome Measures (submitted: April 28, 2020)

• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 3 months ]
  The PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality
• Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache) [ Time Frame: 3 months ]
  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.
• Change in Headache Duration [ Time Frame: baseline to 3 months ]
  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.
• Change in Headache Pain Intensity [ Time Frame: baseline to 3 months ]
  The headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Higher paint intensity score indicates more intense headaches.

Descriptive Information

• Brief Title: Acupuncture in Traumatic Brain Injury
• Official Title: Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Post-traumatic Headache
• Mild Traumatic Brain Injury

Intervention

Procedure: Acupuncture

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.

Study Arms

• Experimental: Low Dose
  Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
  Intervention: Procedure: Acupuncture
• Experimental: High Dose
  Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
  Intervention: Procedure: Acupuncture

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: April 28, 2020): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04369911
• Other Study ID Numbers: A19-094
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: HealthPartners Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: HealthPartners Institute
• Original Study Sponsor: Same as current
• Collaborators: Minnesota Office of Higher Education

Investigators

• Principal Investigator: Amanda A Herrmann, PhD; HealthPartners Neuroscience Research

• PRS Account: HealthPartners Institute
• Verification Date: September 2022