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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
Be older than 18 years old
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreSide effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
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?
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
HealthPartners InstituteLead Sponsor
186 Previous Clinical Trials
3,710,891 Total Patients Enrolled
Amanda A Herrmann, PhDPrincipal InvestigatorHealthPartners Neuroscience Research
2 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other health issues that might make it difficult for you to take part in acupuncture treatments during the study.You are between 18 and 65 years old.You have been diagnosed with a mild traumatic brain injury according to specific medical guidelines.You have a history of chronic headaches.You have a history of serious brain or mental health problems, long-lasting pain disorders, or seizures.You have had acupuncture treatment since being diagnosed with a mild traumatic brain injury.You have a history of bleeding disorders or fainting when getting a needle poke.You have used drugs or alcohol recently or have a current problem with addiction.You were diagnosed with a mild traumatic brain injury (mTBI) between 3 to 12 months ago.You have headaches that started within a week after an injury and have lasted for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose
- Group 2: High Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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