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Neuroscience studies

A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia

Recruitment paused due to COVID-19

Principal Investigator: Michael Rosenbloom, MD

Study Sponsor: HealthPartners Center for Memory and Aging

Location: HealthPartners Neuroscience Center

Phase of Study: Phase 2

Purpose of Study: This study is a single-center, non-randomized, no placebo controlled, feasibility study to assess the safety and tolerability of intranasal insulin in patients with Frontotmporal Dementia (FTD). We will also be evaluating feasibility of using University of California, San Francisco Memory and Aging Center’s EXAMINER battery as a cognitive outcome measure in FTD patients and evaluating the study location’s capacity to recruit for FTD subjects. All enrolled subjects will be asked to self-administer intranasal insulin twice a day, every day for 4 weeks; the estimated duration of subject participation is 9 weeks, as we will be asking subjects to attend 3 in-person visits and be available for 2 phone visits.

Eligible Diagnoses: Frontotemporal Dementia

Study Contact:
(651) 495-6363
ClinicalTrials@HealthPartners.com

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

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Brain Iron Imaging in Parkinson’s Disease

Principal Investigator: Julia Johnson, MD

Study Sponsor: RedFund

Location: HealthPartners Neuroscience Center

Purpose of the Study: In this explorative study we will use Quantitative susceptibility mapping (QSM) to investigate the cerebral iron content in different intracranial regions of interest to answer the question which region has the highest correlation between iron accumulation and cognitive dysfunction in patients with Parkinson’s disease.

Recruitment Status: Recruiting

Study Contact: 651-495-6363

Genentech: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients with Moderate Alzheimer’s Disease

Principal Investigator: Michael Rosenbloom, MD

Study Sponsor: Genentech, Inc.

Phase of Study: Phase 2

Location: HealthPartners Center for Memory and Aging, HealthPartners Institute

Purpose of Study: This study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A in patients with moderate Alzheimer’s disease, ages 50-85. Study drug administration will occur every 2 weeks for the first three doses of the double‑blind treatment period and every 4 weeks thereafter for approximately a year altogether. During this time, individuals will periodically complete cognitive assessments and lab draws to assess safety, efficacy, and clinical outcomes.

Recruitment Status: Active, Not Recruiting

Study Contact:
(651) 495 – 6363
ClinicalTrials@HealthPartners.com

Stroke AF: A Prospective, Multi-Site, Randomized, Controlled, Non-Blinded, Post-Market Study

Principal Investigator: Haitham Hussein, MD

Study Sponsor: Medtronic

Location: Regions Hospital and HealthPartners Neuroscience Center

Purpose of Study: To compare the incidence of atrial fibrillation through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ Insertable Cardiac Monitor and standard-of-care medical treatment in men and women diagnosed with a recent ischemic stroke of presumed known origin. Those who are randomized to the continuous monitoring arm of the study will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of their stroke and undergo continuous remote monitoring. And those who are randomized to the control arm will be followed per site-specific standard of care.

Eligibility: No Longer Recruiting

Study Contact:
(651) 495 – 6363
ClinicalTrials@HealthPartners.com

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