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Acupuncture for Traumatic Brain Injury (AccuTBI Trial)

N/A
Waitlist Available
Led By Amanda A Herrmann, PhD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65
Diagnosis of mild traumatic brain injury (mTBI) as defined by the International classification of headache disorders 3rd edition (ICHD-3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

AccuTBI Trial Summary

This trial will study whether more acupuncture treatments are better than fewer for people with chronic headaches after a brain injury.

Eligible Conditions
  • Chronic Post Traumatic Headache
  • Concussion

AccuTBI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 18 and 65 years old.
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You have been diagnosed with a mild traumatic brain injury according to specific medical guidelines.
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You were diagnosed with a mild traumatic brain injury (mTBI) between 3 to 12 months ago.
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You have headaches that started within a week after an injury and have lasted for at least 3 months.

AccuTBI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in number of headache days
Secondary outcome measures
Adverse Events
Compliance with overall protocol
Compliance with treatment protocol
Other outcome measures
Change in Headache Duration
Change in Headache Pain Intensity
Pittsburgh Sleep Quality Index (PSQI)
+1 more

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811
2%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List

AccuTBI Trial Design

2Treatment groups
Experimental Treatment
Group I: Low DoseExperimental Treatment1 Intervention
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Group II: High DoseExperimental Treatment1 Intervention
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
183 Previous Clinical Trials
3,715,991 Total Patients Enrolled
Minnesota Office of Higher EducationOTHER_GOV
4 Previous Clinical Trials
155 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
20 Patients Enrolled for Post-Traumatic Headache
Amanda A Herrmann, PhDPrincipal InvestigatorHealthPartners Neuroscience Research
2 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT04369911 — N/A
Post-Traumatic Headache Research Study Groups: Low Dose, High Dose
Post-Traumatic Headache Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT04369911 — N/A
Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT04369911 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria do potential participants need to satisfy in order to be enrolled in this research study?

"Candidates that fit the age criteria (18-65) and have wounds may be accepted for this trial; 36 patients are being admitted in total."

Answered by AI

Is geriatric participation welcome in this investigation?

"In accordance with the specified regulations, only individuals aged 18-65 are qualified to join this clinical trial."

Answered by AI

Is enrollment in this experiment currently open?

"Clinicaltrials.gov states that this particular trial, which was first listed on November 23rd 2020 and last amended on September 27th 2022 is no longer recruiting patients. However, there are presently 1050 alternate clinical studies in need of participants."

Answered by AI
~9 spots leftby Mar 2025