Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
Principal Investigator: Amanda Herrmann, PhD
Study Sponsor: Minnesota Office of Higher Education
Location: HealthPartners Neuroscience Center
Purpose of Study: 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 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.
Inclusion Criteria:
- Ability to provide and provision of signed and dated informed consent form
- Age 18-70
- 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 ≤ 2 years 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
- Participation in acupuncture treatment outside of the study, while enrolled
- 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
Study Contact:
(651) 495–6363
ClinicalTrials@HealthPartners.com
All of Us Research Program
Site Principal Investigator: Pamela Pawloski, Pharm.D., BCOP, FCCP
Study sponsor: National Institutes of Health (NIH)
Locations:
-Regions Cancer Care Center
-HealthPartners Neuroscience Center
Purpose of study: HealthPartners Institute is part of the All of Us research program funded by the National Institutes of Health (NIH). The goal of the All of Us research program is to improve health for all of us, for generations to come. The research program is asking people across the United States to join and share their health information and other data to build a large research database that will inform future studies and may even help make the next big medical discovery.
If you are interested you can begin the enrollment process by creating an account online at JoinAllofUs.org. This will give you access to the Participant Portal where you can learn more about the study, complete consent forms, take health surveys, and begin the All of Us journey. If you are eligible, you will be invited to attend an in-person visit at one of our HealthPartners enrollment clinics to have your physical measurements taken and provide blood and urine samples. You will receive a $25 gift card if you are eligible and complete a clinic visit.
Inclusion Criteria: Patients 18 years old or older, current resident of the U.S., not incarcerated
Study Contact:
(952) 967-6911
AllofUs@HealthPartners.com
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum Microbiota (CP101) in Subjects with Recurrent C. Diff
Principal Investigator: Sandeep Bahadur, MD
Study Sponsor: Finch Pharmaceuticals
Location: HealthPartners Specialty Center
Phase of Study: Phase 2
Purpose of Study: The CP101 study is looking at the safety, efficacy, and tolerability of an oral fecal matter transplant (FMT) for patients with recurrent Clostridium Difficile Infection (C.Diff) (>2 recurrences). Eligible patients are randomized to receive either a placebo, low-dose FMT, or high-dose FMT. Patients are then followed for the next 24 weeks for safety measures and C.Diff recurrences.
Inclusion Criteria:
– Ability to provide written informed consent
– Men or women 18 years of age or older
– Current diagnosis of a recurrence of non-severe, non-complicated CDI
– Subject has a clinical response to a standard course of oral vancomycin therapy to treat the current episode of recurrent CDI
Exclusion Criteria:
– Pregnant, breast-feeding, or considering becoming pregnant during the study
– Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn’s disease and ulcerative colitis)
– Any prior diagnosis of irritable bowel syndrome (IBS), or currently meets Rome III criteria for IBS
– Systemic chemotherapy for the treatment of cancer during the 60 days prior to consent or planned during the study
– Prior fecal transplant for any condition, regardless of route of administration
– Presence of ileostomy or colostomy, or history of prior gastric resection or significant colon resection
– Planned hospitalization or invasive surgery during the study
– Severe acute illness unrelated to CDI
Study Contact:
Jenny Koops
(651) 254-5316
Jenny.J.Kooops@HealthPartners.com
