Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture in Traumatic Brain Injury (AccuTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369911
Recruitment Status : Enrolling by invitation
First Posted : April 30, 2020
Last Update Posted : May 11, 2021
Sponsor:
Collaborator:
Minnesota Office of Higher Education
Information provided by (Responsible Party):
HealthPartners Institute

Tracking Information
First Submitted Date  ICMJE April 28, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE November 23, 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Acupuncture in Traumatic Brain Injury
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Post-traumatic Headache
  • Mild Traumatic Brain Injury
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369911
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party HealthPartners Institute
Study Sponsor  ICMJE HealthPartners Institute
Collaborators  ICMJE Minnesota Office of Higher Education
Investigators  ICMJE
Principal Investigator: Amanda A Herrmann, PhD HealthPartners Neuroscience Research
PRS Account HealthPartners Institute
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP